Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorColospan Ltd.
About this trial
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is willing to comply with protocol-specified follow-up evaluations
Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
Patient is diagnosed with colorectal cancer
Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
Disqualifiers
Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
Patients with ASA classification > 3
Albumin < 30 g/liter
Trial design
Design model
Parallel
Treatments tested in this trial
CG-100 intraluminal bypass device
Devicea removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
Stoma
Procedure/SurgeryPrimary protective ileostomy
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: CG-100Experimental treatment 1 intervention
Group B: SOCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Stoma creation rate
Time frame
39 Weeks2
Incidence of complications
Time frame
39 WeeksSponsors and contacts
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Source ClinicalTrials.gov