NCT01682733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Aug 2012

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

August 27, 2012

Last Update Submit

April 6, 2015

Conditions

Obesity

Keywords

ObesityWeight lossGastric reduction (volume)BMI 30-40

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Bariatric Quality of Life (BQL) Questionaire

    baseline to 3 months

Secondary Outcomes (1)

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

    baseline to 3 months

Study Arms (1)

Botulinum toxin at injection site

EXPERIMENTAL

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 toxinDevice: Overstitch Endoscopic Suturing System

Interventions

Botulinum toxinDRUG

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.

Also known as: Botox
Botulinum toxin at injection site
Overstitch Endoscopic Suturing SystemDEVICE

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.

Botulinum toxin at injection site

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Foundation

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31.

    PMID: 26748219DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Botulinum ToxinsBotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Barham K AbuDayyeh, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2012

First Posted

September 11, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)