ColoSeal™ ICD System Safety and Feasibility Study

Colorectal Cancer Clinical Trial

Official title:

European ColoSeal™ ICD System Safety and Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402188
• Other study ID #: CLN0001
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Averto Medical, Inc.
• Contact: Grace Carlson, MD
• Phone: 1-415-518-7043
• Email: grace.carlson[@]avertomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 surgeon's 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 subject's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.

• Subject is diagnosed with rectosigmoid or rectal cancer

• Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).

• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).

• Subject must be willing and able to comply with study follow-up requirements.

Exclusion Criteria:

• Subject with a life expectancy < 1 year

• Subjects with ASA classification > 3

• Albumin < 30 g/liter

• Subject has local or systemic infection at the time of intervention.

• Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study

• Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure

• Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease

• Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression

• BMI = 40

• Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)

• Subject has been taking regular systemic/ steroid medication in the last 3 months

• Subjects is taking antimetabolites or antiplatelet agents

• Subject has undergone a prior pelvic anastomosis

• Subject requires an end-to-end anastomosis smaller than 31 mm in diameter

• Known allergy to any component of the device

• Known allergy to iodine or iodine-based contrast

• Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data

• Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure

• Subject is unable or unwilling to provide informed consent

• Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• ColoSeal ICD Device
The subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10± 2 days. Anastomotic leak testing will be performed prior to scheduled removal.

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Healthycore	Tbilisi
Uzbekistan	National Cancer Institute	Tashkent

Sponsors (1)

Lead Sponsor	Collaborator
Averto Medical, Inc.

Countries where clinical trial is conducted

Georgia,  Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with device related adverse events	Any device related adverse events during procedure and/or follow-up	90 days post procedure
Secondary	Procedure success	Rate of acute efficacy in placing and deploying the device at the desired location	Day 0
Secondary	Procedure time	Time from insertion of the introducer to the vacuum system being ready to be connected and begin vacuum application	Day 0
Secondary	Migration rate	Number of devices migrated over the anastomosis divided by the number of devices placed	Up to 21 days
Secondary	Occurrence of anastomotic leakage	Anastomotic leak rate will be defined as any anastomotic leak during study follow-up period identified on radiographic analysis. Clinically symptomatic and non-symptomatic leaks (radiographically diagnosed only) will be analyzed separately and taken into account during comparative analysis to rates reported in literature. Anastomotic leak rate will be subdivided into those leaks occurring while device is in place in subject or late leaks after device removal.	Up to 90 days post procedure
Secondary	Need for ostomy surgery	Efficacy will be determined by ostomy avoidance rate. Need for ostomy percentage will be defined as the total number of subjects that required ostomy during study follow-up period over total number of subjects enrolled who would have a planned ostomy if not a study participant.	Up to 90 days post procedure
Secondary	Successful device removal	Percent of successful device removals without adverse effect	Up to 21 days