Trials / Completed
CompletedNCT01927562
Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes
Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Fractyl Health Inc. · Industry
- Sex
- All
- Age
- 28 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fractyl Duodenal Remodeling System |
Timeline
- Start date
- 2013-07-13
- Primary completion
- 2017-04-07
- Completion
- 2018-03-16
- First posted
- 2013-08-22
- Last updated
- 2024-02-14
- Results posted
- 2020-03-24
Locations
1 site across 1 country: Chile
Source: ClinicalTrials.gov record NCT01927562. Inclusion in this directory is not an endorsement.