SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression (SEAM)

February 19, 2023 updated by: GI Windows, Inc.

SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression: A Study to Evaluate Safety and Effectiveness of Self-Forming Magnet (SFM) Anastomosis Device: A Historically Controlled Propensity Matched Study

The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a propensity-matched historic control group of patients who underwent ileostomy reversal using a conventional closure technique (sutures or stapler).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 will be 1:1 propensity score matched through nearest neighbor matching to a historical control cohort of patients who underwent ileostomy reversal using conventional closure techniques. 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. Eligibility criteria will be standardized between the prospective investigational treatment arm and the historical control. Within this analysis, propensity score (PS) matching will be used to reduce bias due to potential differences in key covariates between the prospective and retrospective cohorts.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
      • Orlando, Florida, United States, 32806
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Evangelos Messaris, MD, Ph.D
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Medical School
    • Michigan
      • Grand Rapids, Michigan, United States, 49508
        • Recruiting
        • Spectrum Health / Ferguson Clinic
        • Contact:
        • Principal Investigator:
          • James W Ogilvie, MD, MS, FACS, FASCRS
      • Ypsilanti, Michigan, United States, 48197
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Medical Center
        • Principal Investigator:
          • Patricia Sylla, MD
        • Contact:
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St Francis Hospital
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • The Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants must be >18 years
  2. Participant has a temporary loop ileostomy that was created ≥ 2 months but ≤ 10 months prior to reversal. NOTE: The inclusion of patients with ileostomy after total colectomy and palliative ileostomy is permitted if the patients have estimated overall survival of greater than 2 years or if the loop ileostomy is resulting in persistent fluid and electrolyte disorders or other significant stoma related complications where closure of the ileostomy is required for patient safety.
  3. Preoperative clearance with confirmation of anastomotic integrity of the original resection; i.e., absence of active exacerbation of inflammatory disease (as applicable), stricture or leakage at or distal to the diverted colorectal anastomosis via gastrografin enema and/or endoscopy based on physician's discretion
  4. BMI ≤ 40 kg/m2
  5. American Society of Anesthesiologist (ASA) score < IV at time of reversal
  6. All cancer patients must have completed chemotherapy ≥2 months prior to ileostomy closure
  7. Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Institutional Review Board (IRB) and agrees to comply with all protocol-specified follow-up appointments

Exclusion Criteria:

  1. Radiological or clinical signs of anastomosis leak, active infection (except uncomplicated urinary tract infection)
  2. Ongoing or prolonged ileus or bowel obstruction from original surgery
  3. Requires/d additional abdominal surgery (e.g., Major hernia repair, either necessitating mesh and/or abdominal wall reconstruction) after ileostomy or requires/d concurrent abdominal surgery during reversal procedure
  4. Multiple small bowel obstructions occurring between ileostomy creation and closure requiring a formal abdominal exploration through a midline incision at the time of ileostomy closure or any other participant in whom laparotomy is required at time of ileostomy closure
  5. Requires/d laparotomy at time of ileostomy closure
  6. Congestive heart failure with ejection fraction<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
  7. Decompensated chronic obstructive lung disease
  8. Pulmonary embolism or myocardial infarction in the prior 6 months
  9. Congenital or acquired anomalies of the gastrointestinal tract, including atresias, stenosis, luminal distortion or malrotation
  10. Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL at time of reversal
  11. Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Evaluation of the SFM Device
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
Device: Ileostomy Reversal using Self Forming Magnets (SFM)
The magnets will be manually deployed into the small intestine during open surgery following creation of a mini or full laparotomy as clinically indicated. Once the desired segment of small bowel is resected, the magnet is inserted through the open ends of each bowel section. Once proper magnet position is confirmed and the bowel ends are approximated, the magnets couple to form the anastomosis.
Active Comparator: Retrospective Chart Review of Historical Controls
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.
Device: Ileostomy Reversal using Self Forming Magnets (SFM)
The magnets will be manually deployed into the small intestine during open surgery following creation of a mini or full laparotomy as clinically indicated. Once the desired segment of small bowel is resected, the magnet is inserted through the open ends of each bowel section. Once proper magnet position is confirmed and the bowel ends are approximated, the magnets couple to form the anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieving anastomosis success
Time Frame: 30 days
The primary effectiveness hypothesis is that anastomosis success rate for the SFM device will be non-inferior to the anastomosis success rate observed for the propensity-matched historical control group
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GI Windows, Inc.

Investigators

  • Principal Investigator: Evangelos Messaris, MD, Ph.D, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GIW 21-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No: There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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