Trial Outcomes & Findings for Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair (NCT NCT01290666)

NCT ID: NCT01290666

Last Updated: 2017-01-13

Results Overview

• Recruitment status: TERMINATED
• Target enrollment: 93 participants
• Primary outcome timeframe: 12 months post procedure
• Results posted on: 2017-01-13

Participant Flow

A total of 93 subjects were recruited from 11 sites between March of 2011 and September 2013.

Participant milestones

Measure	GORE® BIO-A® Fistula Plug All patients in study receive the GORE® BIO-A® Fistula Plug. Fistula Plug: Bioabsorbable fistula plug
Overall Study STARTED	93
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Measure	GORE® BIO-A® Fistula Plug All patients in study receive the GORE® BIO-A® Fistula Plug. Fistula Plug: Bioabsorbable fistula plug
Overall Study Lost to Follow-up	11
Overall Study Withdrawal by Subject	23
Overall Study Early Termination of Study	4

Baseline Characteristics

Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Baseline characteristics by cohort

Measure	GORE® BIO-A® Fistula Plug n=93 Participants All patients in study receive the GORE® BIO-A® Fistula Plug. Fistula Plug: Bioabsorbable fistula plug
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Gender Female	22 Participants n=5 Participants
Gender Male	71 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post procedure

Outcome measures

Measure	GORE® BIO-A® Fistula Plug n=55 Participants All patients in study receive the GORE® BIO-A® Fistula Plug. Fistula Plug: Bioabsorbable fistula plug
Fistula Closure	35 participants

SECONDARY outcome

Timeframe: Follow up out to 12 months post procedure

Outcome measures

Outcome data not reported

Adverse Events

GORE® BIO-A® Fistula Plug

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GORE® BIO-A® Fistula Plug n=93 participants at risk All patients in study receive the GORE® BIO-A® Fistula Plug. Fistula Plug: Bioabsorbable fistula plug
Infections and infestations Infection	7.5% 7/93 • Number of events 15
General disorders Extrusion	6.5% 6/93 • Number of events 16
General disorders Unresolved Fistula	7.5% 7/93 • Number of events 12
General disorders Other	26.9% 25/93 • Number of events 56

Additional Information

Michael J Stamos, MD

University of California, Irvine

Phone: 888-532-4123

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60