A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)

NCT02839512 | Completed

• 1 other identifier: GIW 14-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center study to assess metabolic effects in subjects after a Jejunal to Ileal Diversion procedure was performed using colonoscopes.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated hemoglobin A1c

  Difference from baseline HbA1c at baseline and HbA1c at 12 months

  12 months

Secondary Outcomes (1)

• Weight loss (%TBWL)

  12 months

Study Arms (1)

Jejunal to Ileal Diversion

EXPERIMENTAL

All subjects who receive jejunal to ileal diversion endoscopic procedure

Device: Jejunal to Ileal Diversion

Interventions

Jejunal to Ileal Diversion DEVICE

The Jejunal to Ileal Diversion procedure will be performed using colonoscopes to place magnets to create a side to side compression anastomosis. The colonoscope delivered magnet creates the proximal end of the anastomosis approximately 100 cm distal from the ligament of Treitz. The colonoscope delivered magnets creates the distal end of the anastomosis approximately 100 cm proximal from the ileocecal junction.

Jejunal to Ileal Diversion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age
• A BMI ≥ 30 kg/m2 and \< 50 kg/m2 If subject has Type 2 Diabetes
• HbA1c ≥ 6.5% and ≤ 9%
• Fasting plasma glucose greater than 110 mg/dl
• Treatment with up to 2 oral diabetic medications
• Able to understand and sign informed consent document
• If subject is female, she must commit to not becoming pregnant for 18 months and agree to use of contraceptives during this period

You may not qualify if:

• Any conditions for which endoscopy/colonoscopy would be contraindicated.
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
• Previous abdomino-pelvic surgery that may result in adhesions or anatomical changes that may interfere with placement of the GIW device.
• Diagnosis of Type 2 diabetes less than 6 months
• More than 2 oral diabetic medications
• Use of insulin
• If on metformin, history of polycystic ovarian syndrome (PCOS)
• Use of Dipeptidyl peptidase-4 (DPP-4) inhibitors
• Use of GLP-1 agonists
• Use of Use of alpha-glucosidase inhibitors
• Type 1 Diabetes
• Unable or unwilling to perform home blood glucose monitoring
• History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
• History of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
• Any blood coagulation disorder

Sponsors & Collaborators

• GI Windows, Inc.: lead

Related Publications (1)

• Machytka E, Buzga M, Zonca P, Lautz DB, Ryou M, Simonson DC, Thompson CC. Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes. Gastrointest Endosc. 2017 Nov;86(5):904-912. doi: 10.1016/j.gie.2017.07.009. Epub 2017 Jul 14.

  PMID: 28716404 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Evžen Machytka

  University of Ostrava Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 21, 2016
• Study Start: October 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2018
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share