Health TrialsbyHealthPanel

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

ConditionsColorectal CancerDiverticular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorGI Windows, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Flexagon SFM plus OTOLoc for Magnet Colon AnastomosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days
2

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

Time frame
30 days

Secondary outcomes

1

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.

Time frame
30 days
2

No Leaks at anastomosis

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

Time frame
30 days
3

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GI Windows, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now