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Recruiting NCT06915818

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

No phase Interventional Colon Anastomosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc.
Who it may be relevant to
Registry conditions: Colon Anastomosis. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile, India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures

Overview

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Detailed description

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Interventions

  • Device Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
    This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of co

Primary outcome measures

  • Number of Participants with Successful Anastomosis Creation without the Need for Reoperation [Time frame: 30 Days]

Eligibility criteria

Inclusion criteria

  • Aged 22 years or older at screening
  • Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) 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 ≥2 months prior to procedure
  • Lives, and intends to remain, within a 300 kilometers 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
  • Diagnosed with obstructed or perforated colon cancer
  • Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
  • Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
  • 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

Chile · 1 center
  • Clinica Colonial Hospital — Santiago
India · 1 center
  • Mohak Hitech Specialty Hospital — Indore

Identifiers

NCT: NCT06915818 · GIW 25-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗