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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc | Experimental | This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc | Device | 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 colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Successful Anastomosis Creation without the Need for Reoperation | The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Lukin | Contact | +1 7814717901 | peter.lukin@giwindows.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD | Mohak Hitech Specialty Hospital | Principal Investigator |
| Vinod Dhakkad, MD | Mohak Hitech Specialty Hospital | Principal Investigator |
| Pablo Marin, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Colonial Hospital | Not yet recruiting | Santiago | Huechuraba, Región Metropolitana | 8580000 | Chile |
There is no plan to make IPD available.
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| Clinica Colonial Hospital |
| Principal Investigator |
| Mohak Hitech Specialty Hospital | Recruiting | Indore | Madhya Pradesh | 454555 | India |
|