ColoSeal™ ICD System Safety and Feasibility Study

NCT ID: NCT06402188

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-08-31

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 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ColoSeal ICD Device Treatment Arm

Subjects will undergo transanal placement of the ICD Device.

Group Type: EXPERIMENTAL

ColoSeal ICD Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Averto Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hurshid Djamshidovich, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Tashkent Uzbekistan

Locations

National Center of Oncology after V.A. Fanarjian

Yerevan, , Armenia

Site Status: RECRUITING

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, , Georgia

Site Status: COMPLETED

National Cancer Institute

Tashkent, , Uzbekistan

Site Status: RECRUITING

Countries

Armenia; Georgia; Uzbekistan

Central Contacts

Grace Carlson, MD

Role: CONTACT

grace.carlson@avertomed.com

1-415-518-7043

Kenton Fong, MD

Role: CONTACT

kenton.fong@avertomed.com

1-650-799-6298

Facility Contacts

Avetiq Petrosyan, MD

Role: primary

avetpetrosian@gmail.com

+374 10 236829

Hurshid Djamshidovich, MD

Role: primary

dr.hurshid@inbox.ru

+998 90 997 84 89

Other Identifiers

CLN0001

Identifier Type: -

Identifier Source: org_study_id