TerminatedNot Applicable

Stomach Intestinal Pylorus-Sparing Bariatric Surgery

Stopped: Recruitment barriers

United States2 participantsStarted 2018-05-17

Plain-language summary

This study will evaluate the safety and efficacy of Stomach Intestinal Pylorus Sparing (SIPS) as a primary bariatric surgery. In addition, we will evaluate the safety and efficacy of SIPS performed as a revisional surgery following sleeve gastrectomy (SG) in which adequate weight loss was not achieved.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-89 * Primary: Satisfies established NIH criteria for bariatric surgery * Revision of sleeve gastrectomy: Sleeve gastrectomy performed at least two years prior but the patient did not reach 50% excess weight loss (EWL), has regained 20% of EWL since sleeve gastrectomy, or has current BMI \> 40 * Willing and able to provide his/her own consent for the surgery Exclusion Criteria: * Contraindication to bariatric surgery * Current pregnancy/breast feeding or plans for pregnancy * Prisoners * Previous history of gastrectomy other than sleeve gastrectomy for weight loss * History of small bowel resection * History of any kind of surgery to treat gastroesophageal reflux disease (GERD) * History of or current Barrett's esophagus * History of or any kind of cancer diagnosis in last 5 years * Large hiatal hernia \> 5 cm

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as a primary procedure

Timeframe: Short-term (30 days)

Efficacy as a primary procedure

Timeframe: Long-term (5 years)

Trial details

NCT IDNCT05094830

SponsorBradley Needleman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

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