A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas

NARecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 20, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

June 30, 2028

Conditions
Anal Fistula
Interventions
DEVICE

RD2 Ver.02

Debridement and suturing of the internal opening of the anal fistula and RD2 Ver.02 coagulating blood application into the fistula tract with a semi flexible cannula.

OTHER

Saline

Debridement and suturing of the internal opening of the anal fistula and Saline administration into the fistula tract with a semi flexible cannula.

Trial Locations (9)

10075

RECRUITING

Lenox Hill Hospital, New York

15212

RECRUITING

Allegheny Health Network, Pittsburgh

33331

RECRUITING

Cleveland Clinic, Weston

46237

RECRUITING

Franciscan Health, Indianapolis

60637

RECRUITING

University of Chicago, Chicago

90048

RECRUITING

Karen Zaghiyan, M.D, Los Angeles

01605

RECRUITING

UMAS, Worcester

02904

RECRUITING

Brown surgical associates, Providence

Unknown

RECRUITING

Sheba Medical Center, Ramat Gan

All Listed Sponsors
lead

RedDress Ltd.

INDUSTRY