ClinicalTrials.gov
ClinicalTrials.gov Menu

Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01927562
Recruitment Status : Active, not recruiting
First Posted : August 22, 2013
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Device: Fractyl Duodenal Remodeling System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes
Study Start Date : August 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duodenal Treatment Device: Fractyl Duodenal Remodeling System



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]
  2. Adverse Event Profile [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants Age > 28 years and ≤ 75 years
  • Male or Female
  • Participants who have signed an informed consent form

Exclusion Criteria:

  • Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
  • Participants with an active systemic infection
  • Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder

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): NCT01927562


Locations
Chile
INDISA
Santiago, Chile
Sponsors and Collaborators
Fractyl Laboratories, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01927562     History of Changes
Other Study ID Numbers: C-10000
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases