NCT02423330

Brief Summary

This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

April 17, 2015

Last Update Submit

September 7, 2021

Conditions

Anal FistulaRectal FistulaFistula in AnoTranssphincteric Fistula

Outcome Measures

Primary Outcomes (1)

  • Healing of the anal fistula

    Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening

    6 months

Secondary Outcomes (3)

  • Healing of the anal fistula

    1 year

  • Postoperative Pain

    1 year

  • Complications

    1 year

Study Arms (1)

Strattice-LIFT

EXPERIMENTAL
Device: Strattice-LIFT

Interventions

Strattice-LIFTDEVICE

Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.

Strattice-LIFT

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is 22 years of age or older
  • Subject is willing to comply with study related procedures
  • Subject is not pregnant
  • Subject has a transsphincteric fistula
  • Subject is medically fit to undergo LIFT
  • Subject has a draining seton for a minimum of 6 weeks

You may not qualify if:

  • Crohn's disease
  • Pelvic radiation treatment
  • Known or suspected HIV/AIDS
  • Known sensitivity to pork products
  • Abscess or fistula etiology other than cryptoglandular
  • Abdominal malignancies
  • Patients with \<1 year life expectancy
  • History of smoking
  • Known anorectal dysfunction (fecal incontinence)
  • Chronic use of steroids or other agents which may affect wound healing
  • ASA ≥ 2
  • Unable to consent to study
  • Unable to complete 1 year follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

US(1)