Endoscopic Gastric Reduction for Weight Management

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barham K. Abu Dayyeh, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01682733
First received: August 27, 2012
Last updated: January 22, 2014
Last verified: January 2014
  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: 10
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682733

Locations
United States, Minnesota
Mayo Foundation
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Barham K AbuDayyeh, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Barham K. Abu Dayyeh, M.D., 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: January 22, 2014
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 July 26, 2014