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OpenTrials
Completed

NCT Number: NCT03218436

Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department for Women's Health

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAP treatment

Procedure

Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.

Primary outcomes

  1. Pathological remission of cervical intraepithelial neoplasia

    Time frame: 3-6 months

    Biopsy, Histopathological examination

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: CAPCIN

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2017
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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