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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 gastro-jejunal anastomosis in participants undergoing gastric 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 gastric-jejunal anastomoses in patients undergoing gastric 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 gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc | Device | This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. 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 | Bhandari Hospital & Research Centre | Principal Investigator |
| Pablo Marin, MD | Clinica Colonial Hospital | Principal Investigator |
| 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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| Mohak Hitech Specialty Hospital | Recruiting | Indore | Madhya Pradesh | 454555 | India |
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