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Endoscopic Gastric Reduction for Weight Management

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ClinicalTrials.gov Identifier: NCT01682733
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Barham K. Abu Dayyeh, M.D., Mayo Clinic

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 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.




Primary Outcome Measures :
  1. Change from baseline Bariatric Quality of Life (BQL) Questionaire [ Time Frame: baseline to 3 months ]

Secondary Outcome Measures :
  1. Change from baseline Three factor Eating Questionnaire (TFEQ-R21) [ Time Frame: baseline to 3 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Barham K. Abu Dayyeh, M.D., Mayo Clinic:
Obesity
Weight loss
Gastric reduction (volume)
BMI 30-40

Additional relevant MeSH terms:
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs