Surgisis Anal Fistula Plug Study: An Experience in Saudi... | NCT00703131

Studies
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

NCT00703131

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Feb 11, 2015Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Anal Fistula

Interventions

Anal Fistula Plug (SurgiSIS AFP)

Countries

Saudi Arabia

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

Apr 2009

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jun 20, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 23, 2008Estimated

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 Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Detailed Description

Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Anal Fistula Plug	Device: Anal Fistula Plug (SurgiSIS AFP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anal Fistula Plug (SurgiSIS AFP)	Device	Anal Fistula Plug	1	SurgiSIS Biodesign

Measure	Description	Time Frame
Healing Success		12 months

Measure	Description	Time Frame
Change in Quality of Life Measures		3, 6, and 12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old or older
Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
Signed informed consent
Willing to return for follow-up visits

Exclusion Criteria:

Crohn's Disease
Ulcerative Colitis
HIV Positive
Immune System Disorder
Collagen Disorder
Tuberculosis
History of radiation to anorectal region
Allergies to pig tissue
Religious or cultural objection to use of pig tissue in this surgical application
J-pouch fistulas
Previous Surgisis AFP Plug placement in target fistula tract
Tracts with acute abscess, infection or inflammation
Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Residents of Saudi Arabia with chronic anal fistula

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad Zubaidi, MD	King Khalid University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Khalid University Hospital		Riyadh		11472	Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula
D005402	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