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ColoSeal™ ICD System Safety and Feasibility Study

NCT06402188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Averto Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Hurshid Djamshidovich, MD · National Cancer Institute Tashkent Uzbekistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • Armenia
  • Georgia
  • Uzbekistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402188 on ClinicalTrials.gov