Colorectal Cancer, Diverticular Diseases
Conditions
Brief summary
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
DEVICEFlexagon 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
Sponsors
GI Windows, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation. | 30 days | The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM plus OTOLoc without placement procedure, device or target anastomosis-related reoperation through 30 days. |
| Anastomosis success | 30 days | is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No Bleeding at anastomosis | 30 days | Bleeding Events through 30 days, defined as a target anastomosis related bleeding at the Flexagon SFM placement site requiring transfusion or re-operation. |
| No Leaks at anastomosis | 30 days | Flexagon SFM anastomosis Leak Events through 30 days, as defined by postoperative upper GI or CT evaluation with findings consistent with anastomosis leak, or re-operative findings consistent with anastomosis leak at the Flexagon SFM placement site |
| No Obstructions at the anastomosis | 30 days | Obstruction Events through 30 days as defined by the need for reintervention (e.g., endoscopic opening) or re-operation resulting from Flexagon SFM placement |
Countries
United States
Contacts
CONTACTPeter J Lukin, BS
CONTACTJessica Musiak, BS
STUDY_CHAIRErik Wilson, MD
Chief Medical Officer
Outcome results
None listed