Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) (CiCi-2021)

University of Thessaly

Status: Unknown

Conditions: Redundant Prepuce; Foreskin; Tightness; Phimosis

Treatments: Procedure: Circumcision in adults; Device: Circumcision in adults using sterile single-use circular stapling device

Study type: Interventional

Funder types: Other

Identifiers

NCT04902898

49616/11.05.2021

Details and patient eligibility

About

Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with pathological foreskin (phimosis, stenosis, redundant prepuce)

Enrollment: 100 estimated patients

Sex: Male

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Circumcision

Other group

Description:

Adult patients treated with circumcision

Treatment:

Procedure: Circumcision in adults

Circumcision with device

Active Comparator group

Description:

Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)

Treatment:

Device: Circumcision in adults using sterile single-use circular stapling device