Condylomata AcuminataNCT02520986
Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma
A study testing Carbon dioxide Laser ablation and Electrocoagulation in people with Condylomata Acuminata, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Condylomata Acuminata
- What is being tested?
- Carbon dioxide Laser ablation and Electrocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 25 Oct 2016to 19 Jan 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- women with anogenital affection of condyloma acuminata
Who cannot join
- significant language barrier
- pregnancy
- unwillingness to participate
- the use of blood thinner or known coagulation disorder
- the use of immunosuppressive medicament
- HIV-Infection
Show all 9Show fewer
- malignant diseases
- local therapy within 8 weeks before Treatment
- wound healing disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625
About this study
Official title: Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Single-center Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
- Conditions
- Condylomata Acuminata
- Being tested
- Carbon dioxide Laser ablation, Electrocoagulation
- Keywords
- Sexually transmitted disease, Genital Warts, Venereal Warts
- Medical subject headings
- Condylomata Acuminata, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide Laser ablationDevice
surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage - NOTE: pulsed 15 W was never used; the actual setting was 5W continuous
ElectrocoagulationDevice
surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide Laser ablation | Experimental | Excision of genital warts using a carbon dioxide laser, ie CO2 Laser Receives: Device: Carbon dioxide Laser ablation |
| Electrocoagulation | Active comparator | Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation Receives: Device: Electrocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic result
Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS)
Measured: 6 weeks
Secondary outcomes (8)
users satisfaction
surgeons will score their satisfaction concerning the used technique by using a 11-step numerical rating scale (NRS) within 30 minutes after surgery
Measured: 30 minutes
Operation time
the time from the beginning of the Treatment until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Measured: 20 minutes
Postoperative pain
patients will score their postoperative pain Level using a 11-step numerical rating scale (NRS) within 5 hours after surgery
Measured: 5 hours
Subjects satisfaction
Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 6 weeks after Treatment
Measured: 6 weeks
Recurrence of genital warts
an examination will be performed 12 weeks after surgery; Recurrence of genital warts will be determined if one or more Areas are infected by genital warts
Measured: 12 weeks
Operative complications
Operative complications defined as necessity to intervene surgically up to 14 days postoperatively (number of patients with operative complications and type of complication)
Measured: 14 days
Subjects satisfaction
Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 12 weeks after Treatment
Measured: 12 weeks
Cosmetic result
Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step numerical rating scale (NRS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start25 Oct 2016
- Primary completion8 Dec 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Tempfer, MD, Ruhr University of Bochum
- Investigators
- Clemens Tempfer, Dr. med., Principal investigator, Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520986
- Sponsor's protocol ID
- CONDYLOMA-1
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2015
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during the current study are not publicly available due to patient confidentiality and institutional data-protection policies, but they can be made available from the corresponding author on reasonable request. Requests will be evaluated to ensure that proposed use complies with ethical approvals and data-use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Single-center Trial Comparing Two Surgical Treatments in Women Undergoing Therapy for Condyloma Acuminata
- ClinicalTrials.gov ID
- NCT02520986
- Acronym / sponsor ID
- CONDYLOMA-1
- Conditions
- Condylomata Acuminata
- Keywords
- Sexually transmitted disease, Genital Warts, Venereal Warts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 13 Aug 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.
In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide Laser ablation | Experimental | Device: Carbon dioxide Laser ablationExcision of genital warts using a carbon dioxide laser, ie CO2 Laser |
| Electrocoagulation | Active comparator | Device: ElectrocoagulationExcision of genital warts using a superficial electrical coagulation mode, ie spray coagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent
- women with anogenital affection of condyloma acuminata
Key exclusion criteria (9 listed)
- significant language barrier
- pregnancy
- unwillingness to participate
- the use of blood thinner or known coagulation disorder
- the use of immunosuppressive medicament
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 |
|---|---|---|
| Carbon dioxide Laser ablationsurgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage - NOTE: pulsed 15 W was never used; the actual setting was 5W continuous | Device | Carbon dioxide Laser ablation |
| Electrocoagulationsurgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage | Device | Electrocoagulation |
Primary outcome
Cosmetic result
Time frame: 6 weeks
Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS)
8 secondary outcomes
users satisfaction
Time frame: 30 minutes
Operation time
Time frame: 20 minutes
Postoperative pain
Time frame: 5 hours
Subjects satisfaction
Time frame: 6 weeks
Recurrence of genital warts
Time frame: 12 weeks
Operative complications
Time frame: 14 days
Subjects satisfaction
Time frame: 12 weeks
Cosmetic result
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during the current study are not publicly available due to patient confidentiality and institutional data-protection policies, but they can be made available from the corresponding author on reasonable request. Requests will be evaluated to ensure that proposed use complies with ethical approvals and data-use agreements.
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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.
Clemens Tempfer, Dr. med. principal investigator
Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide Laser ablation and Electrocoagulation in people with Condylomata Acuminata, run by Ruhr University of Bochum at 1 site in Germany.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 2026. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic result (time frame: 6 weeks). 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 15 Sep 2026.