Endoscopic Gastric Reduction for Weight Management
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-003195
NCT ID: NCT01682733
Sponsor Protocol Number: 12-003195
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Barham Abu Dayyeh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available