WORCESTER, MA--(Marketwire -06/13/12)- The University of Massachusetts Medical School (UMMS) and UMass Memorial Medical Center have enrolled their first participant in a clinical study designed to evaluate a new tissue expansion method for breast reconstruction after a mastectomy. The randomized, controlled clinical study is designed to directly compare the outcomes of the traditional saline tissue expansion method to an investigational, remote-controlled, needle-free, tissue expansion system known as The AeroForm Patient Controlled Tissue Expander System.
Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.
"Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and often painful inflations using conventional saline expanders to create a pocket for a standard implant following a mastectomy," said John Castle, MD, clinical assistant professor of surgery at UMMS and plastic surgery director at the UMass Memorial Comprehensive Breast Center. "This investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander. The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits."
Participants in this clinical trial will undergo outpatient surgery to have the investigational tissue expansion device implanted. They will then use a wireless dose controller to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander, according to a protocol directed by their surgeon. Once the tissue is adequately expanded, participants will return to UMass Memorial Medical Center to have the implant surgically inserted. During earlier feasibility trials, the average expansion time associated with the remote-controlled tissue expander was 15 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.
Patients in the study will be randomly selected to receive the investigational expander or a traditional saline expander. The patients who receive the investigational expander will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander, according to a protocol directed by Dr. Castle. Once the tissue is adequately expanded, the patient will return to have the expander removed and a standard implant placed.
The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for bolus saline injections, which many patients say is the most painful, difficult part of the reconstruction process. The traditional saline process can take as long as five to six months.
UMass Memorial Medical Center and other hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients. AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.
The AeroForm Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment by the U Mass Memorial Medical Center Review Board.
For more information on the study, please visit clinicaltrials.gov. (NCT01425268) If you or someone you know is interested in joining the study, please call 508-334-7692.
About the University of Massachusetts Medical SchoolThe University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $270 million in research funding annually, 80 percent of which comes from federal funding sources. The mission of the Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. For more information, visit http://www.umassmed.edu.
See more here:
UMass Medical School Enrolling Patients in Study of Tissue Expansion for Breast Reconstruction
- "Shift Happens" [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Getting Started With Your Personal Statement [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- I started this blog 1 year ago. I'm ready to become a medical doctor. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Poll Results: "What is your GPA?" [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Why Ross University School of Medicine? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Why Ross University? (Continued) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Filling out applications with the last 4 years in mind. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- "Active and Passive Euthanasia" [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- 300 Word Personal Statement - First Draft [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- 300 Word Personal Statement - 2nd Draft [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- "Where did you do EMT training at?" [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- "is this jonathan that went to brazil in the summer of 2006?" [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- First Application is Away - Ross University [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- AMCAS—The American Medical College Application Service [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Student Doctor Network [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Crime Incident - Public Safety Announcement: STUDENTS [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- AMCAS Deadlines & Delays - Answered [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Headstart on Secondary Applications - The Student Doctor Network [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Complete Medical School & Admissions Guide - Revisited [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Interview Status - Ross University [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Finished my first interview. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- "You have a 95% chance of acceptance..." [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- "I was just wondering if I have to go to medical school i will have to start college allover again." [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Interview Feedback - Allopathic Medical Schools - Ross University School of Medicine (Dominica Caribbean) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- ACCEPTED! [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Step 1 Revisited [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A Few More Thoughts On Moving [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Update [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Closing In [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Internet/Computer Hell [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Back On The Net [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- 1 More Day [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Loan Deferment Blog [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Graduated! [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- What Happened? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Interesting Case [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- What Made Me Stupid? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Blah. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Call [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Medicine in the Media [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Was Medical School Worth It? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Off I Go... [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Is It Worth It, Part 2 [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Oriented [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- GLBT in Medical School [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- GLBT in Residency Applications [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- I Survived [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Reflections on the First Week [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- All Good Things Must End [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Lone Coyote is Back [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Pre-med student switches gears to teach in Chicago school - Chicago Tribune [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Old-school barbecue coming to spot near Fort Worth medical district - Fort Worth Star Telegram [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Nursing home drug use puts many at risk - Boston Globe [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Dr. Anita Figueredo, first female surgeon in San Diego, dies at 93 - Los Angeles Times [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Stimulus funds pay for monkey research in NC - MiamiHerald.com [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Medicine as an economic engine - Buffalo News [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- UM medical school feels the squeeze - MiamiHerald.com [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- HARVARD MEDICAL SCHOOL ADVISER Bell's palsy not as serious as it appears - Detroit Free Press [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Baylor medical school works to get back on track - Houston Chronicle [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- From community college to Amherst College and Yale Medical School - WalletPop (blog) [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- Man questions merit of coke monkey study - UPI.com [Last Updated On: March 8th, 2010] [Originally Added On: March 8th, 2010]
- School Board has questions it wants answered about onsite medical clinic - Terre Haute Tribune Star [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- Stimulus Funds Pay for Monkey Research - NewsMax.com [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- Babylon schools head: Teen's collapse unrelated to athletics - Newsday (subscription) [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- Cost Of Medical School Rises In Recession - NPR [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- Flu Shots in Children Help People of All Ages - New York Times [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- A prescription for improving science education - Scope (blog) [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- Live kidney donors do not die sooner: study - Reuters [Last Updated On: March 9th, 2010] [Originally Added On: March 9th, 2010]
- UW football player suspended after alleged assault - Seattle Post Intelligencer [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- More Comparative Studies Needed to Guide Physicians Study finds less than a ... - ModernMedicine [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Conservationists worry about Mo. med school plan - KOAM-TV [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Dr. William D. Lynn - Baltimore Sun [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Suspect in North Dallas shootings became reclusive after parents died, family says - Dallas Morning News [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Drinkers Gain Less Weight - Harvard Crimson [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Long-Term Health Risks Low for Kidney Donors - WebMD [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- School resource officer remains in critical condition - Middletown Journal [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- New Lucian Leape Institute Report Finds That U.S. Medical Schools Are Falling ... - PR Newswire (press release) [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Dual degrees program expands for Mayo Medical School students - Post-Bulletin [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Comparative Effectiveness Research is a Must - TopNews United States [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Long Beach OKs medical pot ordinance - Contra Costa Times [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]