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Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

NCT01927562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-02-14

Study results available
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Summary

The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.

Conditions

  • Type II Diabetes

Interventions

DEVICE

Fractyl Duodenal Remodeling System

Sponsors & Collaborators

  • Fractyl Health Inc.

    lead INDUSTRY

Principal Investigators

  • Leonard R Gomez, MD · Centro Clinico De La Obesidad

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-13
Primary Completion
2017-04-07
Completion
2018-03-16

Countries

  • Chile

Study Locations

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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 NCT01927562 on ClinicalTrials.gov