Evaluation of the ColoSeal ICD System for protecting colon surgery sites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to assess the safety and feasibility of the ColoSeal ICD System in a multicenter, single-arm format. The device is designed to protect damaged segments of the colon, such as surgical anastomoses, from fecal flow for up to 21 days. Adult patients with rectal and rectosigmoid cancer undergoing resection with a colorectal anastomosis will be the focus of this study. After the anastomosis is completed and confirmed leak-free, the ColoSeal ICD Device will be inserted transanally to provide protection during the critical postoperative period.

Why it matters

Who can join: the full rules

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

Where it's running

• National Center of Oncology after V.A. Fanarjian
  Yerevan, Armenia Recruiting
• National Cancer Institute
  Tashkent, Uzbekistan Recruiting
• Israeli-Georgian Medical Research Clinic Healthycore
  Tbilisi, Georgia Completed

Study contacts

• Principal investigator: Hurshid Djamshidovich, MD — National Cancer Institute Tashkent Uzbekistan
• Study coordinator: Grace Carlson, MD
• Email: grace.carlson@avertomed.com
• Phone: 1-415-518-7043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.