PhimosisCiCi-2021NCT04902898
Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
A study testing Circumcision in adults using sterile single-use circular stapling device and Circumcision in adults in people with Phimosis and Foreskin; Tightness, run by University of Thessaly at 1 site in Greece.
Trial 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) Read more about this study
- Who is it for?
- Ages 16 to 100 years, men only
- Conditions the study is for
- Phimosis, Foreskin; Tightness, Redundant Prepuce
- What is being tested?
- Circumcision in adults using sterile single-use circular stapling device and Circumcision in adults
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 11 May 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce
Exclusion criteria : active inflammation of foreskin
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Urology Department, University of Thessaly, University Hospital of Larissa
Larissa, Larissa/Thessaly, 41110
Vasileios Tzortzis, Professor, 00302413502811, urologydpt.uth@gmail.com
Lampros Mitrakas, Consultant, 00302413501325, lamprosmit@gmail.com
About this study
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
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)
- Conditions
- Phimosis, Foreskin; Tightness, Redundant Prepuce
- Being tested
- Circumcision in adults using sterile single-use circular stapling device, Circumcision in adults
- Medical subject headings
- Phimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumcision in adults using sterile single-use circular stapling deviceDevice
Also called Sterile single-use circular stapling device
Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Circumcision in adultsProcedure or surgery
Also called Circumcision
Circumcision in adults
| Study group | Role | What they receive |
|---|---|---|
| Circumcision | Other | Adult patients treated with circumcision Receives: 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) Receives: Device: Circumcision in adults using sterile single-use circular stapling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Number of gauzes used intraoperatively
Measured: Intraoperatively
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Measured: First postoperative day
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Measured: Seventh postoperative day
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Measured: Twenty first postoperative day
Duration of procedure
Minutes
Measured: 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
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Measured: First postoperative day
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Measured: Seventh postoperative day
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
Measured: Nineteenth postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start11 May 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhimosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Tzortzis, University of Thessaly
- Investigators
- Vasileios Tzortzis, Professor, Principal investigator, Urology Department, University of Thessaly, University Hospital of Larissa, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902898
- Sponsor's protocol ID
- 49616/11.05.2021
- Acronym
- CiCi-2021
- Status last verified
- Jan 2022
- First submitted
- 13 May 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04902898
- Acronym / sponsor ID
- CiCi-2021 / 49616/11.05.2021
- Conditions
- Phimosis, Foreskin; Tightness, Redundant Prepuce
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circumcision | Other | Procedure: Circumcision in adultsAdult patients treated with circumcision |
| Circumcision with device | Active comparator | Device: Circumcision in adults using sterile single-use circular stapling deviceAdult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circumcision in adults using sterile single-use circular stapling deviceAlso: Sterile single-use circular stapling deviceCircumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) | Device | Circumcision with device |
| Circumcision in adultsAlso: CircumcisionCircumcision in adults | Procedure or surgery | Circumcision |
Primary outcome
Bleeding
Time frame: Intraoperatively
Number of gauzes used intraoperatively
Postoperative hematoma
Time frame: First postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative hematoma
Time frame: Seventh postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Postoperative oedema
Time frame: Twenty first postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Duration of procedure
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)
Minutes
3 secondary outcomes
Postoperative oedema
Time frame: First postoperative day
Postoperative oedema
Time frame: Seventh postoperative day
Aesthetic result
Time frame: Nineteenth postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Tzortzis, Professor principal investigator
Urology Department, University of Thessaly, University Hospital of Larissa, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision in adults using sterile single-use circular stapling device and Circumcision in adults in people with Phimosis and Foreskin; Tightness, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Tzortzis, Professor (00302413502811, urologydpt.uth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: Intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022; AzTrials last refreshed its copy on 26 Oct 2026.