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

July 19, 2024 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was completed with Less recruitment as it was planned due to overwhelming study success. The study was published in August 2023. A link has been added to the Reference section.

Study Type

Interventional

Enrollment (Actual)

63

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 Locations

  • Germany
      • Tübingen, Germany, 72076
        • Department for Women's Health

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

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological remission of cervical intraepithelial neoplasia
Time Frame: 3-6 months
Biopsy, Histopathological examination
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human papilloma virus remission rate
Time Frame: 3-6 months
Smear testing
3-6 months
Comfort / Dyscomfort during intervention
Time Frame: Immediately, 2 week, 3-6 months
Freiburger Index of patient comfort
Immediately, 2 week, 3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Melanie Henes, Dr., Department for Women's Health
  • Principal Investigator: Martin Weiss, Dr., Department for Women's Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 1, 2017

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP CIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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