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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis | Experimental | Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation. | 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. | 30 days |
| Anastomosis success | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| No Bleeding at anastomosis | Bleeding Events through 30 days, defined as a target anastomosis related bleeding at the Flexagon SFM placement site requiring transfusion or re-operation. | 30 days |
| No Leaks at anastomosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter J Lukin, BS | Contact | 9787610183 | peter.lukin@giwindows.com | |
| Jessica Musiak, BS | Contact | 617-501-7697 | jessica.musiak@giwindows.com |
| Name | Affiliation | Role |
|---|---|---|
| Erik Wilson, MD | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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|
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
| 30 days |
| No Obstructions at the anastomosis | Obstruction Events through 30 days as defined by the need for reintervention (e.g., endoscopic opening) or re-operation resulting from Flexagon SFM placement | 30 days |
| University of Texas Health Science Center | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000076385 | Diverticular Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |
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