Endoscopic Gastric Reduction for Weight Management
This study is currently recruiting participants.
Verified March 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Christopher J. Gostout, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01682733
First received: August 27, 2012
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Botulinum toxin Device: Overstitch Endoscopic Suturing System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Change from baseline Bariatric Quality of Life (BQL) Questionaire [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline Three factor Eating Questionnaire (TFEQ-R21) [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 6 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: Botox
Device: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Body Mass Index (BMI) between 30 and 40
- Age >18 and ≤50
- Stable weight for 3 months (within 5% of BMI)
- Normal basic labs (CBC, chemistry profile, creatinine)
- Negative pregnancy test for females >18 or ≤ 50
Exclusion Criteria:
- Diabetes
- Unstable coronary artery disease
- Heart failure
- Cardiac arrhythmia
- Cardiac valvular disease
- Obstructive of interstitial lung disease
- Females of child-bearing age >18 or ≤ 50 who are pregnant or lactating
- Mallampati score of 4
- ASA 3 or above
- Previous gastric surgery
- Ulcer disease
- Gastroparesis,
- > 5 cm Hiatal hernia
- Congenital anomalies of the GI tract
- Currently on or prescribed a medication known to affect weight within 3 months of study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682733
Locations
| United States, Minnesota | |
| Mayo Foundation | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Christopher J. Gostout, MD 507-266-3972 gostout.christopher@mayo.edu | |
| Sub-Investigator: Barham K Abu Dayyeh, MD | |
| Sub-Investigator: Maria L Collazo Clavell, MD | |
| Sub-Investigator: Elizabeth Rajan, MD | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Christopher Gostout, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Christopher J. Gostout, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01682733 History of Changes |
| Other Study ID Numbers: | 12-003195 |
| Study First Received: | August 27, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Obesity Weight loss Gastric reduction (volume) BMI 30-40 |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Botulinum Toxins Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013