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New surgery shows promise for obesity and diabetes

NCT ID NCT04627103

Disease control Sponsor: GI Windows, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a surgery that combines two procedures to help people with obesity and type 2 diabetes lose weight and control their blood sugar. 18 adults aged 19-65 with a BMI between 35 and 50 took part. Researchers measured weight loss and metabolic changes over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 19-65 years at screening * Body mass index (BMI) ≥35 and ≤50 * T2DM diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \< 10.0% at time of enrollment. * HbA1c must be stable over a 3-month period. * Weight stable over 3-month period * Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled * Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * Able to understand and sign informed consent documents. Exclusion Criteria: * Known or suspected allergy to nickel or titanium or nitinol * Type 1 diabetes or poorly controlled type 2 diabetes * Use of injectable insulin * Any documented conditions for which endoscopy would be contraindicated * Contraindication to general anesthesia * History of chronic gastrointestinal disease * Congenial or acquired anomalies of the GI tract * Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * Uncontrolled hypertension * Pre-existing severe comorbid cardio-respiratory disease * History of chronic gastrointestinal disease * Specific genetic or hormonal cause of obesity * Recent tobacco/nicotine product cessation (within 3 months prior)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus metabolic disease Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Type 2 diabetes mellitus

Contacts and locations

Locations

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Université Laval

    Québec, Quebec, G1V 4G5, Canada

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