Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

NCT ID: NCT02520986

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-12-01

Brief Summary

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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 visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.

Detailed Description

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Conditions

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Condylomata Acuminata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Carbon dioxide Laser ablation

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

Group Type EXPERIMENTAL

Carbon dioxide Laser ablation

Intervention Type DEVICE

surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage

Electrocoagulation

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

Group Type ACTIVE_COMPARATOR

Electrocoagulation

Intervention Type DEVICE

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

Interventions

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Carbon dioxide Laser ablation

surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage

Intervention Type DEVICE

Electrocoagulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* informed consent
* women with anogenital affection of condyloma acuminata

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zydolab - Institute of Cytology and Immune Cytochemistry

OTHER

Sponsor Role lead

Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Responsible Party

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Dr. med. Ziad Hilal

Dr. med. Ziad Hilal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziad Hilal, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Zydolab - Institute of Cytology and Immune Cytochemistry

Locations

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Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ziad Hilal, Dr. med.

Role: CONTACT

+49231529747

Facility Contacts

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Clemens Tempfer, M.D.

Role: primary

02323 499 1801

Other Identifiers

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CONDYLOMA-1

Identifier Type: -

Identifier Source: org_study_id

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