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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05046730
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
GI Windows, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Retraction of Ileostomy Device: Ileostomy Reversal using Self Forming Magnets (SFM) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : April 30, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must be >18 years and <80 years
  2. Participant has a temporary loop ileostomy that was created ≥ 2 months but ≤ 10 months prior to reversal
  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. Index operation was a total proctocolectomy or palliative stoma
  4. 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
  5. 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
  6. Requires/d laparotomy at time of ileostomy closure
  7. 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)
  8. Decompensated chronic obstructive lung disease
  9. Pulmonary embolism or myocardial infarction in the prior 6 months
  10. Congenital or acquired anomalies of the gastrointestinal tract, including atresias, stenosis, luminal distortion or malrotation
  11. Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL at time of reversal
  12. Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysi
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046730


Contacts
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Contact: Peter J Lukin 9787610183 peter.lukin@giwindows.com

Locations
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United States, Florida
Colon and Rectal Clinical of Orlando Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Nancy Joiner       NJoiner@crcorlando.com   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Anna George       ageorge5@bidmc.harvard.edu   
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Penny J Doughty       Penny.J.Doughty@hitchcock.org   
United States, New York
The Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Deepika Bhasin    212-241-4863    Deepika.Bhasin@montsinai.org   
Principal Investigator: Patricia Sylla, MD         
St Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago, RN, CCRC    516-562-6763    Lyn.santiago@chsli.org   
United States, North Carolina
Novant Health Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: David Hiller, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Michael Deutsch, MD       mdeutsch1@pennstatehealth.psu.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Joan Kaiser       joan.l.kaiser@vumc.org   
United States, Texas
UT Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Angielyn Rivera       angielyn.r.rivera@uth.tmc.edu   
United States, Wisconsin
The Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kathryn Hoffman, MS, CCRP    414-955-1479    khoffman@mcw.edu   
Sponsors and Collaborators
GI Windows, Inc.
Investigators
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Principal Investigator: Evangelos Messaris, MD, Ph.D Beth Israel Deaconess Medical Center
More Information
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Responsible Party: GI Windows, Inc.
ClinicalTrials.gov Identifier: NCT05046730    
Other Study ID Numbers: GIW 21-002
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes