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Tests treatment safety and results for Colorectal Cancer
Official title ColoSeal™ ICD System Safety and Feasibility Study
ClinicalTrials.gov ID: NCT06402188
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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)...
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the...
- Subject must be willing and able to comply with study follow-up requirements.
You likely can't join if
- Subject with a life expectancy \< 1 year
- people with ASA classification \> 3
- Albumin \< 30 g/liter
- Subject has local or systemic infection at the time of intervention.
- Major surgical or treatment procedures within 30 days prior to this study or planned major surgical or treatment procedures within 1 month of entry...
- Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure
See the full eligibility 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...
- 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.
- Subject with a life expectancy \< 1 year
- people with ASA classification \> 3
- Albumin \< 30 g/liter
- Subject has local or systemic infection at the time of intervention.
- Major surgical or treatment procedures within 30 days prior to this study or planned major surgical or treatment 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
- people 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
- people 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Armenia
- Tbilisi, Georgia
- Tashkent, Uzbekistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Armenia; Tbilisi, Georgia; Tashkent, Uzbekistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.