Endoscopic Gastric Reduction for Weight Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01682733|
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Botulinum toxin Device: Overstitch Endoscopic Suturing System||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study|
|Study Start Date :||August 2012|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Experimental: Botulinum toxin at injection site
All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.
Drug: Botulinum toxin
In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.
Other Name: BotoxDevice: Overstitch Endoscopic Suturing System
The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
- Change from baseline Bariatric Quality of Life (BQL) Questionaire [ Time Frame: baseline to 3 months ]
- Change from baseline Three factor Eating Questionnaire (TFEQ-R21) [ Time Frame: baseline to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682733
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Barham K AbuDayyeh, MD||Mayo Clinic|