Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe the Flexagon 25mm SFM system plus OTOLoc is and how well it joins parts of the bowel during colon surgery. It is for adults age 22 or older who need certain colon surgeries. The study checks whether the bowel join is successful without another related surgery within 30 days.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 22 or older.
- You need surgery to remove part of your colon or rectum and have medical approval for surgery.
- You can understand and sign the study consent form.
- Your ASA score, which rates your health before anesthesia, is below 4.
- If you have cancer, you finished chemotherapy at least 1 month before surgery.
- You live within 150 miles of the study center and plan to stay there during the study.
- You can avoid smoking during study follow-up.
Who can't join
- You have a known or suspected allergy to silicone, nickel, titanium, or Nitinol; a BMI over 55; or uncontrolled diabetes with an HbA1c over 10%.
- You have bowel problems that could block the study magnet, repeated small bowel blockages, or colon cancer with a current blockage or hole in the bowel.
- A scope exam or small-cut surgery is unsafe for you, a past failed scope exam suggests delivery problems, or you cannot safely have general anesthesia.
- You have untreated blood-clotting problems, platelets below 50,000, high blood potassium, blood that clots too easily, or a past clot in a vein or lung.
- You have moderate to severe kidney disease with an eGFR below 44, need dialysis, have heart failure with pumping strength below 35%, have certain serious heart rhythm problems, or have chronic lung disease that is not controlled.
- Your immune system is weakened by illness or treatment, or your surgery site has a known or suspected infection or a contaminated or infected wound.
- You are breastfeeding, pregnant, or planning to become pregnant during follow-up.
- You received an experimental drug, device, or biologic treatment in another trial within the past 30 days, or the study doctor decides this trial is not right for you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Aged 22 years or older at screening 2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery 3. Able to understand and sign informed consent document 4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure 5. All cancer patients must have completed chemotherapy ≥1 months prior to procedure 6. Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study 7. Able to refrain from smoking during study follow-up period Exclusion Criteria: 1. Known or suspected allergy to silicone, nickel, titanium or Nitinol 2. BMI \> 55 kg/m2 3. Uncontrolled diabetes (defined as HbA1c \>10%) 4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet 5. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit 6. 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 7. History of recurrent small bowel obstructions. 8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL 9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis 10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism 11. 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 12. 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) 13. Decompensated chronic obstructive lung disease 14. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. 15. Contraindication to general anesthesia 16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period 17. 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 18. Contraindication to general anesthesia 19. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Study sites (2)
FL
- Orlando Health · Orlando, FL 32806Antonio Caycedo, MD., MSc · Study contact · 407-422-3790 · antonio.caycedo@orlandohealth.comMore trials in Orlando
TX
- University of Texas Health Science Center · Houston, TX 77030Erik Askenasy, MD · Study contactErik Askenasy, MD · Principal investigatorMore trials in Houston