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A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas

NCT02456324 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-05-28

No results posted yet for this study

Summary

The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal fistulas.

Conditions

  • Anal Fistulas
  • Rectal Fistulas

Interventions

DEVICE

PICS-AF Device

This is a specialized closure system for anorectal fistulas that is sphincter sparing

DEVICE

Historical Controls Treated with Commercially Available Fistula Plugs

These are patients previously treated with commercially available fistula plugs.

Sponsors & Collaborators

  • Curaseal Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-05-31
Completion
2016-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456324 on ClinicalTrials.gov