Ligation of the Intersphincteric Fistula Tract (LIFT) + B... | NCT01602081

Studies
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula

NCT01602081

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Feb 11, 2015Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Anal Fistula

Interventions

reinforce soft tissue

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

May 16, 2012

First Submission Date that Met QC Criteria

May 17, 2012

First Posted Date

May 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2015

Last Update Posted Date

Feb 11, 2015Estimated

Description Module

Brief Summary

The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LIFT+Biodesign			Device: reinforce soft tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reinforce soft tissue	Device	reinforce soft tissue	LIFT+Biodesign

Measure	Description	Time Frame
Closure of the anal fistula		6 months

Measure	Description	Time Frame
Closure of the anal fistula		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria:

Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
Fistula with multiple tracts
Recto-vaginal fistula
Active infection in the anal fistula
Physical allergies or cultural objections to porcine products
Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
Previous diagnosis of collagen disorder
History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Regional and Community Hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California Irvine		Orange	California	92868	United States
Rush University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided