Endoscopic Gastric Reduction for Weight Management

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01682733

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Botulinum toxin Device: Overstitch Endoscopic Suturing System	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Change from baseline Bariatric Quality of Life (BQL) Questionaire [baseline to 3 months]

Secondary Outcome Measures

Change from baseline Three factor Eating Questionnaire (TFEQ-R21) [baseline to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.