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Procedure

Magnetic Anastomosis Device for Ileostomy Reversal (SEAM Trial)

N/A
Recruiting
Led By Evangelos Messaris, MD, Ph.D, FACS
Research Sponsored by GI Windows, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

SEAM Trial Summary

This trial is testing a new device to close the small intestine after an ileostomy reversal, to see if it is safe and effective compared to conventional methods.

Who is the study for?
Adults over 18 with a BMI ≤ 40 kg/m2 who had a temporary loop ileostomy created between 2-10 months ago can join. They must have an expected survival of over 2 years, no severe complications from the original surgery, and completed any chemotherapy at least 2 months before. Participants need to be medically stable without serious heart, lung, kidney issues or coagulation deficiencies.Check my eligibility
What is being tested?
The SEAM Trial is testing a new method for reconnecting the small bowel using Self Forming Magnets (SFM) in patients needing their ileostomy reversed. It's compared against traditional methods like sutures or staples based on past patient experiences.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of magnet placement, infection risk due to bowel reconnection, possible intestinal blockage if magnets don't work properly, and general risks associated with surgical procedures.

SEAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achieving anastomosis success

SEAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective Evaluation of the SFM DeviceExperimental Treatment1 Intervention
This is a multicenter, single-arm study in which clinical outcomes prospectively evaluated for a minimum of 100 subjects undergoing ileostomy reversal using the SFM Anastomosis Device
Group II: Retrospective Chart Review of Historical ControlsActive Control1 Intervention
In order to have a sufficient pool of retrospective patients for matching, retrospective data will be collected for a minimum of 300 patients. The historical control cohort will be accrued from the same pool of institutions participating in the prospective study.

Find a Location

Who is running the clinical trial?

GI Windows, Inc.Lead Sponsor
7 Previous Clinical Trials
140 Total Patients Enrolled
Evangelos Messaris, MD, Ph.D, FACSPrincipal InvestigatorBeth Israel Deaconess Medical Center
Evangelos Messaris, MD, Ph.DPrincipal InvestigatorBeth Israel Deaconess Medical Center

Media Library

Ileostomy Reversal using Self Forming Magnets (SFM) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05046730 — N/A
Retraction of Ileostomy Research Study Groups: Prospective Evaluation of the SFM Device, Retrospective Chart Review of Historical Controls
Retraction of Ileostomy Clinical Trial 2023: Ileostomy Reversal using Self Forming Magnets (SFM) Highlights & Side Effects. Trial Name: NCT05046730 — N/A
Ileostomy Reversal using Self Forming Magnets (SFM) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046730 — N/A

Frequently Asked Questions

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

What sort of individuals might qualify as participants in this experiment?

"This clinical trial is recruiting 400 individuals from the age of 18 up to 80, whose ileostomy has been retracted. Prospective participants must meet certain prerequisites which include: surpassing the age of majority, a temporary loop ileostomy established within 2-10 months before reversal and BMI ≤ 40 kg/m2, with an American Society of Anesthesiologist (ASA) score < IV at time of reversal. In addition, cancer patients need to have completed chemotherapy ≥2 months prior to ileostomy closure. Furthermore, all involved parties should be aware that they are participating in this study as well as follow protocol"

Answered by AI

Is there an age cap for participants of this clinical experiment?

"This research is looking for volunteers aged 18-80."

Answered by AI

What is the uppermost limit of participants involved in this medical experiment?

"In order to progress this medical trial, 400 qualified patients need to be enrolled. Those who meet the criteria can participate in locations such as Vanderbilt University Medical Center, located in Nashville Tennessee and The Medical College of Wisconsin based in Milwaukee Wisconsin."

Answered by AI

At what number of healthcare centers is this experiment being conducted?

"Patients can enroll in this medical trial at several locations, including Vanderbilt University Medical Center (Nashville, Tennessee), The Medical College of Wisconsin (Milwaukee, Wisconsin), and Dartmouth Hitchcock Medical Center (Lebanon, New hampshire). Additionally there are 8 other sites available."

Answered by AI

Is this investigation currently recruiting participants?

"Affirmative. Per the data hosted on clinicaltrials.gov, this medical trial is currently enrolling participants and was first posted on February 1st 2022 before being updated last October 24th 2022. 400 individuals are expected to be recruited from 11 different hospitals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression
2022. "SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046730.
~126 spots leftby Apr 2025
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