Obesity
Conditions
Keywords
Obesity, Weight loss, Gastric reduction (volume), BMI 30-40
Brief summary
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.
Interventions
DRUGBotulinum 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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Bariatric Quality of Life (BQL) Questionaire | baseline to 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Three factor Eating Questionnaire (TFEQ-R21) | baseline to 3 months |
Countries
United States
Outcome results
None listed