Urethral CaruncleNCT02490228
Effectivity and Safety Study of Trans-artificial-urethral Resection of Female Urethral Caruncle
A study testing TAURFUC in people with Urethral Caruncle, run by Peking University First Hospital.
Trial summary
To explore the minimally invasive and exhaustive treatment of female urethral canruncle by using trans-artificial-urethral resection of the canruncle. The investigators plant to recruit patients using this surgical method and study the effectivity of this method. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urethral Caruncle
- What is being tested?
- TAURFUC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with urethral caruncle
Who cannot join
- recurrence urethral caruncle
Trial locations and contacts
No sites are listed yet.
About this study
To explore the minimally invasive and exhaustive treatment of female urethral canruncle by using trans-artificial-urethral resection of the canruncle. The investigators plant to recruit patients using this surgical method and study the effectivity of this method.
- Conditions
- Urethral Caruncle
- Being tested
- TAURFUC
- Keywords
- female, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAURFUCProcedure or surgery
female patients with urethral caruncle will receive transurethral resection combine with extension tube.
| Study group | Role | What they receive |
|---|---|---|
| surgical group | Other | transurethral resection of urethral caruncle Receives: Procedure: TAURFUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: Up to 6 months
Length of hospital stay
Measured: Up to 6 months
Estimated blood loss
Measured: Up to 6 months
pathological type
Measured: Up to 6 months
Complication incidence rate
Measured: Up to 6 months
Secondary outcomes (1)
recurrence-free survival
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral CaruncleStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490228
- Sponsor's protocol ID
- TAURFUC
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity and Safety Study of Trans-artificial-urethral Resection of Female Urethral Caruncle
- ClinicalTrials.gov ID
- NCT02490228
- Acronym / sponsor ID
- TAURFUC
- Conditions
- Urethral Caruncle
- Keywords
- female, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- 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.
To explore the minimally invasive and exhaustive treatment of female urethral canruncle by using trans-artificial-urethral resection of the canruncle. The investigators plant to recruit patients using this surgical method and study the effectivity of this method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical group | Other | Procedure: TAURFUCtransurethral resection of urethral caruncle |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with urethral caruncle
Key exclusion criteria (1 listed)
- recurrence urethral caruncle
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 |
|---|---|---|
| TAURFUCfemale patients with urethral caruncle will receive transurethral resection combine with extension tube. | Procedure or surgery | surgical group |
Primary outcome
Operative time
Time frame: Up to 6 months
Length of hospital stay
Time frame: Up to 6 months
Estimated blood loss
Time frame: Up to 6 months
pathological type
Time frame: Up to 6 months
Complication incidence rate
Time frame: Up to 6 months
1 secondary outcome
recurrence-free survival
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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.
Questions about this trial
What is this clinical trial studying?
A study testing TAURFUC in people with Urethral Caruncle, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Xuesong Li, MD (+86-10-83575101, pineneedle@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Up to 6 months). 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 3 Jul 2015.