ClinicalTrials.gg
CompletedNCT02520986Updated Sep 15, 2026

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

An interventional study of Carbon dioxide Laser ablation and Electrocoagulation in Condylomata Acuminata, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Ruhr University of Bochum · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Condylomata Acuminata

Keywords

  • Sexually transmitted disease
  • Genital Warts
  • Venereal Warts
03

In context

Condylomata Acuminata

116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.

This study's enrollment of 140 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 126 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women with anogenital affection of condyloma acuminata

Exclusion criteria

Exclusion Criteria:

  • significant language barrier
  • pregnancy
  • unwillingness to participate
  • the use of blood thinner or known coagulation disorder
  • the use of medicament
  • -Infection
  • malignant diseases
  • local therapy within 8 weeks before Treatment
  • wound healing disorder
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Carbon dioxide Laser ablation

    Excision of genital warts using a carbon dioxide laser, ie CO2 Laser

    Device: Carbon dioxide Laser ablation

  • Active comparator
    Electrocoagulation

    Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation

    Device: Electrocoagulation

Interventions

  • DeviceCarbon dioxide Laser ablation

    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

  • DeviceElectrocoagulation

    surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage

06

What researchers measure

Primary outcomes

  1. Cosmetic result

    Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step numerical rating scale (NRS)

    Time frame: 6 weeks

Secondary outcomes

  1. 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

    Time frame: 30 minutes

  2. 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

    Time frame: 20 minutes

  3. Postoperative pain

    patients will score their postoperative pain Level using a 11-step numerical rating scale (NRS) within 5 hours after surgery

    Time frame: 5 hours

  4. Subjects satisfaction

    Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 6 weeks after Treatment

    Time frame: 6 weeks

  5. 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

    Time frame: 12 weeks

  6. 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)

    Time frame: 14 days

  7. Subjects satisfaction

    Patients will score their Overall satisfaction by using a 11-step numerical rating scale (NRS) 12 weeks after Treatment

    Time frame: 12 weeks

  8. Cosmetic result

    Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step numerical rating scale (NRS)

    Time frame: 12 weeks

07

Study locations

1 site
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum
    Herne, North Rhine-Westphalia 44625, Germany
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Dec 2025, 109 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2015
First posted
Aug 13, 2015
StartActual
Oct 25, 2016
Primary completionActual
Dec 8, 2025
CompletionActual
Jan 19, 2026
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02520986
Responsible party
Clemens Tempfer, MD (Principal Investigator, Ruhr University of Bochum) — Principal investigator
First posted
Aug 13, 2015
Start date
Oct 25, 2016
Primary completion
Dec 8, 2025
Completion
Jan 19, 2026
Last update
Sep 15, 2026

Study contacts

Clemens Tempfer, Dr. med.
principal investigator · Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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