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SIPS Surgery for Obesity (SIPS Trial)

N/A

Recruiting

Led By Bradley Needleman, MD

Research Sponsored by Bradley Needleman

Eligibility Criteria Checklist

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

Must have

Primary: Satisfies established NIH criteria for bariatric surgery

Willing and able to provide his/her own consent for the surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up long-term (5 years)

Awards & highlights

SIPS Trial Summary

This trial will study if a stomach-sparing surgery is a safe and effective way to treat obesity, both as a primary surgery and as a revision surgery for patients who didn't lose enough weight with a sleeve gastrectomy.

Who is the study for?

This trial is for adults aged 18-89 who meet NIH criteria for bariatric surgery or those needing a revision after sleeve gastrectomy because they didn't lose enough weight. Candidates must be able to consent to the procedure and not be pregnant, breastfeeding, planning pregnancy, imprisoned, or have had certain previous surgeries.Check my eligibility

What is being tested?

The study tests the SIPS bariatric surgery's safety and effectiveness as both an initial obesity treatment and as a follow-up procedure if prior sleeve gastrectomy failed to achieve significant weight loss.See study design

What are the potential side effects?

Potential side effects of SIPS may include typical surgical risks such as infection, bleeding, reaction to anesthesia, nutrient deficiencies due to altered digestion process, and possible need for additional surgeries.

SIPS Trial Eligibility Criteria

Inclusion Criteria

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

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I meet the NIH criteria for weight loss surgery.

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I am willing and able to consent to surgery myself.

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I am between 18 and 89 years old.

SIPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ long-term (5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~long-term (5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and long-term (5 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

Efficacy as a primary procedure

Safety as a primary procedure

SIPS Trial Design

1Treatment groups

Experimental Treatment

Group I: Stomach Intestinal Pylorus Sparing (SIPS)Experimental Treatment1 Intervention

Patients undergoing SIPS procedure as their bariatric surgery of choice.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bradley NeedlemanLead Sponsor

Bradley Needleman, MDPrincipal InvestigatorThe Ohio State University College of Medicine

Media Library

Stomach Intestinal Pylorus-Sparing (SIPS) Procedure Clinical Trial Eligibility Overview. Trial Name: NCT05094830 — N/A

Obesity Research Study Groups: Stomach Intestinal Pylorus Sparing (SIPS)

Obesity Clinical Trial 2023: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure Highlights & Side Effects. Trial Name: NCT05094830 — N/A

Stomach Intestinal Pylorus-Sparing (SIPS) Procedure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094830 — N/A

Frequently Asked Questions

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

How many participants are currently being included in this investigation?

"Affirmative. Clinicaltrials.gov reflects that this clinical investigation, initially posted on May 17th 2018, is currently recruiting test subjects. 25 participants are necessary to be enrolled at one specific trial site."

Answered by AI

Is there an opportunity to participate in this research endeavor?

"This research is recruiting 25 obese adults aged between 18 and 89 who have either had a sleeve gastrectomy but only achieved 50% of their expected weight loss, regained 20% of the weight since it was performed or has a Body Mass Index (BMI) higher than 40. Moreover, all participants must be amenable to consenting for surgery voluntarily."

Answered by AI

Can you confirm if recruitment is still underway for this research endeavor?

"Indeed, the information available on clinicaltrials.gov confirms that this study is currently in search of participants. Initially posted on May 17th 2018 and most recently updated October 15 2021, it requires 25 people from a single medical centre to take part."

Answered by AI

Does this research accept participants of a mature age?

"This study is open to adolescents aged 18 and above, up until those in their late eighties. Additionally, 202 clinical trials are available for minors while 596 can be accessed by elderly patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stomach Intestinal Pylorus-Sparing Bariatric Surgery

Bradley Needleman 2018. "Stomach Intestinal Pylorus-Sparing Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05094830.