ColoSeal ICD System for Rectal Cancer

Not yet recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 22 and 75 years old and have rectal cancer.
I am 71-75 years old and have good physical and mental health scores.
I need a stapled connection in my lower bowel within 10 cm of my anus.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ColoSeal ICD System or undergo standard care for rectal cancer surgery

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

270 days

What Are the Treatments Tested in This Trial?

Interventions

  • ColoSeal™ ICD System

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Averto Medical, Inc.

Lead Sponsor

Trials
1
Recruited
20+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+