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Procedure

SADI Surgery Revision for Obesity (SADI Trial)

N/A

Waitlist Available

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI 40+ kg/m2 with no comorbidities; AND

having lost less than 10% total weight loss with this LSG; AND

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

SADI Trial Summary

This trial is testing a new weight-loss surgery to see if it's effective and safe. The surgery is for people who have already had one weight-loss surgery that didn't work well enough.

Who is the study for?

This trial is for adults who are Kaiser Permanente members, have a BMI of 40+ without other health issues or a BMI of 35-39 with comorbidities, and have had less than 10% weight loss after a laparoscopic sleeve gastrectomy. It's not for those under 18, with severe GERD, hiatal hernia, previous bariatric revisions other than LSG, or a primary bariatric procedure different from LSG.Check my eligibility

What is being tested?

The study tests the Single Anastomosis Duodenal Ileal Bypass (SADI) as an additional treatment for patients who didn't lose enough weight following their initial laparoscopic sleeve gastrectomy. The aim is to provide another option for significant weight loss and improvement in obesity-related conditions.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with SADI may include nutritional deficiencies due to reduced absorption of food nutrients, gastrointestinal symptoms like diarrhea or nausea, surgical complications such as leaks or infections.

SADI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 40 or more and I have no other health conditions.

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I have lost less than 10% of my total weight with this surgery.

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I am 18 years old or older.

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I have had a laparoscopic sleeve gastrectomy.

SADI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Total Weight Loss (change in weight relative to baseline)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,113,039 Total Patients Enrolled

34 Trials studying Obesity

113,050 Patients Enrolled for Obesity

Media Library

Laparoscopic Sleeve Gastrectomy (LSG) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04165694 — N/A

Obesity Clinical Trial 2023: Laparoscopic Sleeve Gastrectomy (LSG) Highlights & Side Effects. Trial Name: NCT04165694 — N/A

Laparoscopic Sleeve Gastrectomy (LSG) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165694 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for individuals to participate in this clinical trial?

"As evidenced on clinicaltrials.gov, participation in this trial is no longer possible as recruitment has been completed. It was originally made available to prospective participants on October 15th 2019 and the data was last updated January 11th 2022. At present, there are 146 other trials actively recruiting patients for their studies."

Answered by AI

Would I be eligible to join this experiment?

"This clinical trial is searching for 54 individuals who have a diagnosis of obesity, severe and are aged between 18 to 100."

Answered by AI

Could those aged in excess of thirty years qualify for this research?

"The eligibility requirements for this medical trial only accept participants between the ages of 18 and 100. Separately, there are 10 studies that cater to individuals under the age of 18 while 114 trials focus on patients above 65 years old."

Answered by AI