Treatment of Anal Fistulas With Obsidian RFT® | NCT06136325

Studies
Treatment of Anal Fistulas With Obsidian RFT®

NCT06136325

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Anal Fistula
Minimal Invasive Surgery
Platelet-rich Fibrin Foam

Interventions

Obsidian RFP anal fistula surgery

Countries

Austria

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

Nov 2023

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 17, 2018Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Oct 27, 2023Actual

First Submitted Date

Oct 29, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

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

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Christopher Dawoud, Principal Investigator; MD, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Detailed Description

Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal passages between the anal canal and surrounding tissues. Traditional treatments, while effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence. Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. In this context, our retrospective study aims to evaluate the efficacy and safety of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its success in fistula closure and functional outcomes, thus contributing to the advancement of sphincter-preserving methods in anal fistula management.

Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases.

Demographic, comorbidity, fistula characteristics, and postoperative data were collected from electronic records.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

18Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obsidian RFP anal fistula surgery	Procedure	Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Closure rate anal fistula	anal fistula closure rate according to documentation in the patient administration system	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna

Exclusion Criteria:

unclear documentation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

All patients, receiving an anal fistula closure with Obsidian RTF®, were included into the final analysis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Dawoud, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39095560	Derived	Dawoud C, Girgis K, Stift A, Harpain F, Riss S. Treatment of anal fistulas with Obsidian RFT(R): just another autologous compound platelet-rich fibrin foam? Tech Coloproctol. 2024 Aug 2;28(1):93. doi: 10.1007/s10151-024-02968-6.

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