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Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia (CAPCIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218436
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief Summary:

Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort.

Primary endpoint after 3-6 months: Pathological remission.

Secondary endpoint: HPV remission.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Procedure: CAP treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: CAP cohort
Cold Atmospheric plasma intervention
Procedure: CAP treatment
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.

No Intervention: Control cohort
no intervention



Primary Outcome Measures :
  1. Pathological remission of cervical intraepithelial neoplasia [ Time Frame: 3-6 months ]
    Biopsy, Histopathological examination


Secondary Outcome Measures :
  1. Human papilloma virus remission rate [ Time Frame: 3-6 months ]
    Smear testing

  2. Comfort / Dyscomfort during intervention [ Time Frame: Immediately, 2 week, 3-6 months ]
    Freiburger Index of patient comfort



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for CAP:

  • Histologically confirmed CIN I / II
  • Reliable assessment of the radius of the portio and marginal borders of the lesions
  • Written consent for treatment with low temperature plasma after reconnaissance

Inclusion Criteria for Control-Group:

  • Histologically confirmed CIN I / II
  • Reliable assessment of the radius of the portio and marginal borders of the lesions
  • Patients who want a waiting procedure and a control examination after 3-6 months

Exclusion Criteria:

  • Histologically confirmed CIN III
  • Not fully visible transformation zone
  • An indication of invasive disease
  • Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial
  • Severe cardio-vascular disease
  • Lack of patient consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218436


Contacts
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Contact: Melanie Henes, Dr. +49 70712982211 melanie.henes@med.uni-tuebingen.de
Contact: Martin Weiss, Dr. +49 70712982211 martin.weiss@med.uni-tuebingen.de

Locations
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Germany
Department for Women's Health Recruiting
Tübingen, Germany, 72076
Contact: Miriam Linneweh, Dr    004970712985380    miriam.linneweh@med.uni-tuebingen.de   
Sponsors and Collaborators
University Women's Hospital Tübingen
Investigators
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Principal Investigator: Melanie Henes, Dr. Department for Women's Health
Principal Investigator: Martin Weiss, Dr. Department for Women's Health
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Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT03218436    
Other Study ID Numbers: CAP CIN
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type