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

Primary Purpose

Phimosis, Foreskin; Tightness, Redundant Prepuce

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Circumcision in adults using sterile single-use circular stapling device
Circumcision in adults
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phimosis

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin

Sites / Locations

  • Urology Department, University of Thessaly, University Hospital of LarissaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Circumcision

Circumcision with device

Arm Description

Adult patients treated with circumcision

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

Outcomes

Primary Outcome Measures

Bleeding
Number of gauzes used intraoperatively
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Duration of procedure
Minutes

Secondary Outcome Measures

Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Aesthetic result
Visual analogue scale from 0 to 10, as follows: 0 - 5 = unsatisfactory, 6 - 7 = moderately satisfactory, 8 - 9 = very satisfactory, 10 = excellent, according to the patient's estimation

Full Information

First Posted
May 13, 2021
Last Updated
January 25, 2022
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT04902898
Brief Title
Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Acronym
CiCi-2021
Official Title
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 Adult Patients Suffering From Pathologic Foreskin (Phimosis, Stenosis, Redundant Prepuce): A Prospective Randomised Comparative Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis, Foreskin; Tightness, Redundant Prepuce

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circumcision
Arm Type
Other
Arm Description
Adult patients treated with circumcision
Arm Title
Circumcision with device
Arm Type
Active Comparator
Arm Description
Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Intervention Type
Device
Intervention Name(s)
Circumcision in adults using sterile single-use circular stapling device
Other Intervention Name(s)
Sterile single-use circular stapling device
Intervention Description
Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Intervention Type
Procedure
Intervention Name(s)
Circumcision in adults
Other Intervention Name(s)
Circumcision
Intervention Description
Circumcision in adults
Primary Outcome Measure Information:
Title
Bleeding
Description
Number of gauzes used intraoperatively
Time Frame
Intraoperatively
Title
Postoperative hematoma
Description
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time Frame
First postoperative day
Title
Postoperative hematoma
Description
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time Frame
Seventh postoperative day
Title
Postoperative oedema
Description
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time Frame
Twenty first postoperative day
Title
Duration of procedure
Description
Minutes
Time Frame
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 Outcome Measure Information:
Title
Postoperative oedema
Description
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time Frame
First postoperative day
Title
Postoperative oedema
Description
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time Frame
Seventh postoperative day
Title
Aesthetic result
Description
Visual analogue scale from 0 to 10, as follows: 0 - 5 = unsatisfactory, 6 - 7 = moderately satisfactory, 8 - 9 = very satisfactory, 10 = excellent, according to the patient's estimation
Time Frame
Nineteenth postoperative day
Other Pre-specified Outcome Measures:
Title
Pain feeling
Description
Visual analogue scale from 0 to 10, as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = very severe pain and 10 = worst possible pain, according to the patient's estimation
Time Frame
Intraoperatively
Title
Anaesthesia
Description
Quantity of applied lidocaine hydrochloride 2% w/v in milliliters
Time Frame
Immediately preoperatively
Title
Used sutures
Description
Absolute number of used sutures
Time Frame
Intraoperatively

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males suffer from foreskin pathologic conditions
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce Exclusion criteria : active inflammation of foreskin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasileios Tzortzis, Professor
Phone
00302413502811
Email
urologydpt.uth@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lampros Mitrakas, Consultant
Phone
00302413501325
Email
lamprosmit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasileios Tzortzis, Professor
Organizational Affiliation
Urology Department, University of Thessaly, University Hospital of Larissa, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Department, University of Thessaly, University Hospital of Larissa
City
Larissa
State/Province
Larissa/Thessaly
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasileios Tzortzis, Professor
Phone
00302413502811
Email
urologydpt.uth@gmail.com
First Name & Middle Initial & Last Name & Degree
Lampros Mitrakas, Consultant
Phone
00302413501325
Email
lamprosmit@gmail.com
First Name & Middle Initial & Last Name & Degree
Vasileios Tzortzis, Professor
First Name & Middle Initial & Last Name & Degree
Lampros Mitrakas, Consultant

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
After a publication and for a period of 2 years

Learn more about this trial

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

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