Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402188
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-05-07
Brief Title:
ColoSeal ICD System Safety and Feasibility Study
Sponsor:
Averto Medical Inc
Organization:
Averto Medical Inc
Study Overview
Official Title:
European ColoSeal ICD System Safety and Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective multicenter single-arm study The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis anastomosis leak or perforation from contact with fecal flow for up to 21 days The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis
Detailed Description:
The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective multicenter single-arm study The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis anastomosis leak or perforation from contact with fecal flow for up to 21 days The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis Subjects will undergo scheduled resection per the surgeons preferred technique Following completion of the colon anastomosis a leak check will be performed prior to insertion of the ColoSeal ICD Device to confirm no leak is present The ICD Device will be inserted advanced and positioned with the ICD Delivery System transanally The anchor portion is positioned 5 cm above and ideally 10-20 cm above more proximal in GI tract the area requiring protection from fecal flow the anastomosis The anchor portion of the device is designed to be placed in healthy bowel and not at the region of damaged bowel where protection is required After positioning deployment and anchoring of the ICD Device the Delivery System is removed The external portion of the device is further anchored to the subjects skin using an adhesive dressing and an optional extension tubing The ICD Device will remain in place for 10-2 days post-operatively An anastomosis leak test will be performed prior to device removal Once no leak is confirmed the ICD Device will be removed from the subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None