Retrospective Review of the Cook Biodesign® Fistula Plug to Treat

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01913249` - Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula	N/A
Completed	`NCT04357210` - Anal Sphincter Reconstruction After High Recurrent Anorectal Fistula Excision
Recruiting	`NCT01478139` - Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair	Phase 3

See also

Status

Clinical Trial

Phase

Withdrawn

NCT01913249 - Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

N/A

Completed

NCT04357210 - Anal Sphincter Reconstruction After High Recurrent Anorectal Fistula Excision

Recruiting

NCT01478139 - Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03321266
Study type	Observational
Source	Cook Group Incorporated
Contact
Status	Completed
Phase
Start date	November 30, 2017
Completion date	August 29, 2019

Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms