SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression (SEAM)
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| ClinicalTrials.gov Identifier: NCT05046730 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2021
Last Update Posted : October 25, 2022
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Sponsor:
GI Windows, Inc.
Information provided by (Responsible Party):
GI Windows, Inc.
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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 |
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 (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 : | October 1, 2023 |
| Estimated Study Completion Date : | December 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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
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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. |
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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.
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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. |
Primary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
| Contact: Peter J Lukin | 9787610183 | peter.lukin@giwindows.com |
Locations
| United States, Florida | |
| Advent Health | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Diana Paredes, RN diana.paredes@adventhealth.com | |
| Principal Investigator: Matthew Albert, MD | |
| 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 | |
| Principal Investigator: Evangelos Messaris, MD, Ph.D | |
| 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: Hannah Son 212-241-8835 Hannah.Son@mountsinai.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
| Principal Investigator: | Evangelos Messaris, MD, Ph.D | Beth Israel Deaconess Medical Center |
| 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: | October 25, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No: There is not a plan to make IPD available. |
| 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 |