NCT04902898

Brief Summary

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

May 13, 2021

Last Update Submit

January 25, 2022

Conditions

PhimosisForeskin; TightnessRedundant Prepuce

Outcome Measures

Primary Outcomes (5)

  • Bleeding

    Number of gauzes used intraoperatively

    Intraoperatively

  • Postoperative hematoma

    Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation

    First postoperative day

  • Postoperative hematoma

    Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation

    Seventh postoperative day

  • Postoperative oedema

    Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation

    Twenty first postoperative day

  • Duration of procedure

    Minutes

    Intraoperative (Measurement begins at the time of the beginning of the sterilisation of the surgical field and ends at the time of the completion of the bandeage of the wound)

Secondary Outcomes (3)

  • Postoperative oedema

    First postoperative day

  • Postoperative oedema

    Seventh postoperative day

  • Aesthetic result

    Nineteenth postoperative day

Other Outcomes (3)

  • Pain feeling

    Intraoperatively

  • Anaesthesia

    Immediately preoperatively

  • Used sutures

    Intraoperatively

Study Arms (2)

Circumcision

OTHER

Adult patients treated with circumcision

Procedure: Circumcision in adults

Circumcision with device

ACTIVE COMPARATOR

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

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

Interventions

Circumcision in adults using sterile single-use circular stapling deviceDEVICE

Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)

Also known as: Sterile single-use circular stapling device
Circumcision with device
Circumcision in adultsPROCEDURE

Circumcision in adults

Also known as: Circumcision
Circumcision

Eligibility Criteria

Age16 Years - 100 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males suffer from foreskin pathologic conditions
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department, University of Thessaly, University Hospital of Larissa

Larissa, Larissa/Thessaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Phimosis

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Vasileios Tzortzis, Professor

    Urology Department, University of Thessaly, University Hospital of Larissa, Greece

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Tzortzis, Professor

CONTACT

00302413502811urologydpt.uth@gmail.com

Lampros Mitrakas, Consultant

CONTACT

00302413501325lamprosmit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 26, 2021

Study Start

May 11, 2021

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
After a publication and for a period of 2 years

Locations

GR(1)