CClinicalTrials.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

Who can participate

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

Inclusion criteria

  • informed consent
  • 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 immunosuppressive medicament
  • HIV-Infection
  • malignant diseases
  • local therapy within 8 weeks before Treatment
  • wound healing disorder
04

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

05

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

06

Study locations

1 site
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum
    Herne, North Rhine-Westphalia 44625, Germany
07

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.

08

Registry details

Key details

Study ID
NCT02520986
Lead sponsor
Ruhr University of Bochum
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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion