Treatment of Urethral Stricture With Urethral Drug Ball

Summary

To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.

Conditions

• Urethral Stricture Less Than 2 cm

Interventions

PROCEDURE

Drug balloon dilatation

The Drug balloon is covered with paclitaxel coating that diffuses the drug into the urethral wall when dilated

PROCEDURE

Direct vision internal urethrotomy (DVIU)

A control subject will choose DVIU surgery until the desired effect is achieved

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jianbing Li · Beijing Tsinghua Changgeng Hospital

• Jianbin Bi · First Hospital of China Medical University

• Qiang Fu · Shanghai 6th People's Hospital

• Shaogang Wang · Tongji Hospital affiliated to Tongji Medical College HUST

• Xiaoping Zhang · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Yuanjie Niu · Tianjin Medical University Second Hospital

• Jinjian Yang · The First Affiliated Hospital of Zhengzhou University

• Weijun Qin · Air Force Medical University of PLA (the Fourth Military Medical University)

• Lei Li · First Affiliated Hospital Xi'an Jiaotong University

• Deyi Luo · West China School of Medicine of Sichuan University

• Zhansong Zhou · Southwest Hospital, China

• Wei Yu · Peking University First Hospital

• Jianwei Wang · Beijing Jishuitan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-31

Primary Completion

2024-10-31

Completion

2025-02-28

Countries

• China

Study Locations