NCT06402188 ColoSeal™ ICD System Safety and Feasibility Study
| NCT ID | NCT06402188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Averto Medical, Inc. |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-06-05 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
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 * Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function * 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 (with the exception of aspirin) * Subject has undergone a prior pelvic anastomosis * Subject requires an end-to-end anastomosis smaller than 31 mm in diameter * Inadequate bowel preparation prior to the procedure * Anastomotic leak detected during intraoperative leak testing * Known allergy to any component of the device * Known allergy to iodine or iodine-based contrast unless subject can be adequately premedicated prior to leak test * Subject has unresolved alcohol abuse or illegal drug use * 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
Contact & Investigator
Hurshid Djamshidovich, MD
PRINCIPAL INVESTIGATOR
National Cancer Institute Tashkent Uzbekistan
Frequently Asked Questions
Who can join the NCT06402188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06402188 currently recruiting?
Yes, NCT06402188 is actively recruiting participants. Contact the research team at grace.carlson@avertomed.com for enrollment information.
Where is the NCT06402188 trial being conducted?
This trial is being conducted at Yerevan, Armenia, Tbilisi, Georgia, Tashkent, Uzbekistan.
Who is sponsoring the NCT06402188 clinical trial?
NCT06402188 is sponsored by Averto Medical, Inc.. The principal investigator is Hurshid Djamshidovich, MD at National Cancer Institute Tashkent Uzbekistan. The trial plans to enroll 90 participants.
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