- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520986
Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma
January 24, 2023 updated by: Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
Carbon Dioxide Laser Ablation Versus Electrocoagulation - a Prospective, Randomized Multicenter 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 visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ziad Hilal, Dr. med.
- Phone Number: +49231529747
- Email: z.hilal@zydolab.de
Study Locations
-
-
NRW
-
Herne, NRW, Germany, 44625
- Recruiting
- Department of Obstetrics and Gynecology of the Ruhr University Bochum
-
Contact:
- Clemens Tempfer, M.D.
- Phone Number: 02323 499 1801
- Email: Clemens.Tempfer@elisabethgruppe.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carbon dioxide Laser ablation
Excision of genital warts using a carbon dioxide laser, ie CO2 Laser
|
surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage
|
Active Comparator: Electrocoagulation
Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation
|
surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmetic result
Time Frame: 6 weeks
|
Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
users satisfaction
Time Frame: 30 minutes
|
surgeons will score their satisfaction concerning the used technique by using a 11-step visual analogue scale (VAS) within 30 minutes after surgery
|
30 minutes
|
Operation time
Time Frame: 20 minutes
|
the time from the beginning of the Treatment until the end of the operation (the end of hemostatic interventions) will be measured in minutes
|
20 minutes
|
Postoperative pain
Time Frame: 5 hours
|
patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) within 5 hours after surgery
|
5 hours
|
Subjects satisfaction
Time Frame: 6 weeks
|
Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 6 weeks after Treatment
|
6 weeks
|
Recurrence of genital warts
Time Frame: 12 months
|
an examination will be performed 12 months after surgery; Recurrence of genital warts will be determined if one or more Areas are infected by genital warts
|
12 months
|
Operative complications
Time Frame: 14 days
|
Operative complications defined as necessity to intervene surgically up to 14 days postoperatively (number of patients with operative complications and type of complication)
|
14 days
|
Subjects satisfaction
Time Frame: 12 weeks
|
Patients will score their Overall satisfaction by using a 11-step visual analogue scale (VAS) 12 weeks after Treatment
|
12 weeks
|
Cosmetic result
Time Frame: 12 weeks
|
Cosmetic result judged by the Patient 12 weeks after Treatment using a 11-step visual analogue scale (VAS)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ziad Hilal, Dr. med., Zydolab - Institute of Cytology and Immune Cytochemistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 11, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 24, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CONDYLOMA-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Condylomata Acuminata
-
Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...Completed
-
Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...Active, not recruiting
-
Maruho Co., Ltd.Leiden University Medical CenterCompletedCondylomata Acuminata (External)Netherlands
-
VaxartCompletedCondylomaArgentina, Chile, Ecuador, Serbia
-
Shenzhen Second People's HospitalUnknown
-
Laboratorio Elea Phoenix S.A.TerminatedRecurrent Condyloma | Nonrecurrent CondylomaArgentina
-
G&E Herbal Biotechnology Co., LTDCompletedGenital Warts | Condylomata Acuminata | Condyloma Acuminata | Venereal WartsTaiwan
-
Integra LifeSciences CorporationActive, not recruitingCondylomata Acuminata | Vulvar Intraepithelial NeoplasiaUnited States
-
BioMAS LtdCompletedCondyloma Acuminata | Wart; External Genital OrgansIsrael
-
Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...CompletedCervical Cancer | Condylomata AcuminataChina
Clinical Trials on Carbon dioxide Laser ablation
-
Qilu Hospital of Shandong UniversityRecruitingStress Urinary IncontinenceChina
-
Rambam Health Care CampusCompletedStress Urinary IncontinenceIsrael
-
Cairo UniversityCompleted
-
Rambam Health Care CampusRecruitingSexual DysfunctionIsrael
-
Sun Yat-sen UniversityRecruitingKeratosis | Eyelid Tumor | Pigmented Nevi | Xanthelasma PalpebrarumChina
-
Cairo UniversityCompleted
-
Massachusetts General HospitalUnited States Department of Defense; Shriners Hospitals for ChildrenCompleted
-
Henry Ford Health SystemCompletedHidradenitis SuppurativaUnited States
-
Moy-Fincher Medical GroupUnknown