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Can a second bypass surgery rescue failed weight loss?

NCT ID NCT04165694

Disease control Sponsor: Kaiser Permanente 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at whether a follow-up surgery called Single Anastomosis Duodenal Ileal Bypass (SADI) can help people who had a sleeve gastrectomy but didn't lose enough weight. Participants are adults with severe obesity who lost less than 10% of their body weight after the first surgery. The goal is to see if this second procedure leads to more weight loss and improves obesity-related health problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Single Anastomosis Duodenal Ileal Bypass (SADI), a surgical procedure that reroutes the intestine to reduce calorie absorption
What this could lead to
If successful, this could offer a reliable second-step surgery for people with severe obesity who didn't lose enough weight after a sleeve gastrectomy, potentially improving weight loss and related health conditions.
What could go wrong
This is a relatively small study, and the procedure carries surgical risks like any major operation. Results may not apply to all patients, and long-term benefits are still uncertain.

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

54 people

The number who actually took part.

Started

Oct 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Body Mass Index (BMI) 35 - 39 kg/m2 with comorbid conditions; OR 2. BMI 40+ kg/m2 with no comorbidities; AND 3. having a previous laparoscopic sleeve gastrectomy (LGS); AND 4. having lost less than 10% total weight loss with this LSG; AND 5. being a Kaiser member at the time of surgery; AND 6. being at least 18 years of age. Exclusion Criteria: 1. BMI less than 35 kg/m2; OR 2. having a hiatal hernia; OR 3. having severe Gastroesophageal Reflux Disease; OR 4. having a primary bariatric procedure other than LSG; OR 5. having already had a revisional bariatric procedure; OR 6. being less than 18 years old.

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Conditions

The condition(s) this trial relates to.

morbid obesity

As listed by the trial registrant

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

Bariatric surgery candidate Severe obesity

Contacts and locations

Locations

  • Kaiser Permanente Southern California West Los Angeles Medical Center

    Los Angeles, California, 90034, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.