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ReShape Medical begins weight-loss study
San Clemente-based firm conducts a trial of its nonsurgical dual-balloon device.
By Ashly McGlonePublished: March 09, 2010 02:38 PM
San Clemente-based medical product manufacturer ReShape Medical Inc. has begun an Investigational Device Exemption clinical study for its nonsurgical dual-balloon weight-loss device in the U.S.
The device is inserted into the stomach during a 15-minute outpatient procedure and remains in place for six months, reducing the capacity for food.
The dual-balloon product has been approved for clinical use as a weight-loss treatment in other countries, with patients losing 40 to 60 pounds during a six-month period, according to ReShape Medical.
The first U.S. study participant is a 31-year-old Newport Beach resident who weighs 263 pounds and stands at 6 feet 2 inches. The participant, who did not qualify for bariatric surgery, is under the care of Dr. Brian Quebbemann, surgical director of The N.E.W. Program in Newport Beach.
"Countless Americans have grown beyond a healthy weight and struggle with conventional methods of weight loss, but can't or won't undergo surgery,” says Quebbemann. “This group is ideally suited for a nonsurgical weight-loss treatment such as the ReShape device being evaluated in this study."
Clinical studies are being conducted in Orange County, as well as Portland, Ore., and Dalton, Ga., and will last one year. An Investigational Device Exemption allows the treatment to be used in a clinical trial to collect data before being submitted to the Food and Drug Administration for approval.
Eligible candidates for the study must be between the ages of 20 and 60 and have a Body Mass Index between 30 and 40, among other qualifications.
ReShape Medical is a development-stage medical device manufacturer focused on nonsurgical weight-loss devices.
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The device is inserted into the stomach during a 15-minute outpatient procedure and remains in place for six months, reducing the capacity for food. The dual-balloon product has been approved for clinical use as a weight-loss treatment in other countries, with patients losing 40 to 60 pounds during a six-month period, according to ReShape Medical. The first U.S. study participant is a 31-year-old Newport Beach resident who weighs 263 pounds and stands at 6 feet 2 inches. The participant, who did not qualify for bariatric surgery, is under the care of Dr. Brian Quebbemann, surgical director of The N.E.W. Program in Newport Beach. "Countless Americans have grown beyond a healthy weight and struggle with conventional methods of weight loss, but can't or won't undergo surgery,” says Quebbemann. “This group is ideally suited for a nonsurgical weight-loss treatment such as the ReShape device being evaluated in this study." Clinical studies are being conducted in Orange County, as well as Portland, Ore., and Dalton, Ga., and will last one year. An Investigational Device Exemption allows the treatment to be used in a clinical trial to collect data before being submitted to the Food and Drug Administration for approval. Eligible candidates for the study must be between the ages of 20 and 60 and have a Body Mass Index between 30 and 40, among other qualifications. ReShape Medical is a development-stage medical device manufacturer focused on nonsurgical weight-loss devices. Related headlines Ellen Clark Skin Care International forms in Irvine Mission Viejo Microsoft Store takes title sponsorship for hospital luncheon OC METRO, March issue: 'Kept in suspension' |
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