Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

Official title

Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures

Overview

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.

Detailed description

This is a prospective, single-center, single-arm, early feasibility clinical study.

Patients who are scheduled for laparoscopic colon surgery requiring an anastomosis will be evaluated for participation in the study.

Study Cohorts:

* Roll-In (Training) Cohort: A roll-in phase will be included for centers that do not have previous experience with the SFM device. A maximum of 3 roll-in participants will be enrolled. Data from roll-in participants will be summarized separately from the Primary Analysis Cohort. * Primary Analysis Cohort: A minimum of 17 participants undergoing side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc.

Patients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Flexagon SFM System plus OTOLoc and procedures will be performed under general anesthesia.

Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.

Interventions

• Device Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
  The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection

Primary outcome measures

• Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation. [Time frame: 30 days]
• Anastomosis success [Time frame: 30 days]

Secondary outcome measures (3)

• No Bleeding at anastomosis [Time frame: 30 days]
• No Leaks at anastomosis [Time frame: 30 days]
• No Obstructions at the anastomosis [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

• Aged 22 years or older at screening
• Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
• Able to understand and sign informed consent document
• American Society of Anesthesiologists (ASA) score < IV at time of procedure
• All cancer patients must have completed chemotherapy ≥1 months prior to procedure
• Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
• Able to refrain from smoking during study follow-up period

Exclusion criteria

• Known or suspected allergy to silicone, nickel, titanium or Nitinol
• BMI > 55 kg/m2
• Uncontrolled diabetes (defined as HbA1c >10%)
• Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
• Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
• History of recurrent small bowel obstructions.
• Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
• Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
• Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
• Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
• 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
• Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
• Contraindication to general anesthesia
• Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
• Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
• Contraindication to general anesthesia
• Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Orlando Health — Orlando
• University of Texas Health Science Center — Houston

Identifiers

NCT: NCT07276529 · 25-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗