A Trial of the Jejunal to Ileal Diversion Endoscopic Proc... | NCT02839512

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

NCT02839512

Sponsor

GI Windows, Inc.

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Jejunal to Ileal Diversion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jul 11, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The Jejunal to Ileal Diversion procedure is an adaptation of a biliopancreatic diversion with duodenal switch, which is a surgical procedure used to treat metabolic syndrome conditions. The small bowel diversion of the jejunum into the ileum by creating a single anastomosis just beyond the ligament of Trietz will be studied. Up to 15 eligible subjects will be enrolled into the trial. Enrollment will stop once 10 subjects have undergone the Jejunal to Ileal Diversion procedure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jejunal to Ileal Diversion	Experimental	All subjects who receive jejunal to ileal diversion endoscopic procedure	Device: Jejunal to Ileal Diversion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in glycosylated hemoglobin A1c	Difference from baseline HbA1c at baseline and HbA1c at 12 months	12 months

Secondary Outcomes

Measure	Description	Time Frame
Weight loss (%TBWL)	Difference from baseline total body weight loss at baseline and total body weight loss at 12 months	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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
Implanted cardiac pacemaker, defibrillator or other implanted electric device - Ongoing systemic infection
Chronic pancreatitis
Chronic liver disease of any cause
Poorly controlled psychiatric disease (e.g. ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis)
Any history of an eating disorder within the past 5 years
Pre-existing severe comorbid cardio-respiratory disease (e.g. congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism)
Uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Evžen Machytka	University of Ostrava Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28716404	Result	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases