SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Retraction of Ileostomy

Intervention / Treatment
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* Device: Ileostomy Reversal using Self Forming Magnets (SFM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be >18 years 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. 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 BMI ≤ 40 kg/m2 American Society of Anesthesiologist (ASA) score < IV at time of reversal All cancer patients must have completed chemotherapy ≥2 months prior to ileostomy closure 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: Radiological or clinical signs of anastomosis leak, active infection (except uncomplicated urinary tract infection) Ongoing or prolonged ileus or bowel obstruction from original surgery 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 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 Requires/d laparotomy at time of ileostomy closure 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) Decompensated chronic obstructive lung disease Pulmonary embolism or myocardial infarction in the prior 6 months Congenital or acquired anomalies of the gastrointestinal tract, including atresias, stenosis, luminal distortion or malrotation Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL at time of reversal Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Evaluation of the SFM Device<br>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)<br>* 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.<br>|
| Active Comparator: Retrospective Chart Review of Historical Controls<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving anastomosis success | 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 |