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Completed

NCT Number: NCT01682733

Endoscopic Gastric Reduction for Weight Management

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Foundation

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

Botulinum toxin

Drug

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

Overstitch Endoscopic Suturing System

Device

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.

Primary outcomes

  1. Change from baseline Bariatric Quality of Life (BQL) Questionaire

    Time frame: baseline to 3 months

Secondary outcomes

  1. Change from baseline Three factor Eating Questionnaire (TFEQ-R21)

    Time frame: baseline to 3 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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