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A Feasibility Study for the Treatment of Primary Obesity

NCT03837691 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-19

No results posted yet for this study

Summary

This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity.

Conditions

Interventions

DEVICE

Placement of Snowshoe Suture Anchors

Snowshoe suture anchors from g-Cath EZ Delivery Catheters are placed in the stomach with the aid of a Transport, g-Lix and g-Prox device

BEHAVIORAL

Moderate Intensity Diet & Exercise Program

After placement of the snowshoe suture anchors in the stomach, subjects are asked to follow a moderate intensity diet and exercise program

Sponsors & Collaborators

  • USGI Medical

    lead INDUSTRY

Principal Investigators

  • Barham Abu Dayyeh, MD · Mayo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2023-06-15
Completion
2023-10-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837691 on ClinicalTrials.gov