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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CAP treatment
Sponsored by
University Women's Hospital Tübingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department for Women's Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CAP cohort

Control cohort

Arm Description

Cold Atmospheric plasma intervention

no intervention

Outcomes

Primary Outcome Measures

Pathological remission of cervical intraepithelial neoplasia
Biopsy, Histopathological examination

Secondary Outcome Measures

Human papilloma virus remission rate
Smear testing
Comfort / Dyscomfort during intervention
Freiburger Index of patient comfort

Full Information

First Posted
July 13, 2017
Last Updated
January 12, 2021
Sponsor
University Women's Hospital Tübingen
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1. Study Identification

Unique Protocol Identification Number
NCT03218436
Brief Title
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
Acronym
CAPCIN
Official Title
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Women's Hospital Tübingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAP cohort
Arm Type
Active Comparator
Arm Description
Cold Atmospheric plasma intervention
Arm Title
Control cohort
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Procedure
Intervention Name(s)
CAP treatment
Intervention Description
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
Primary Outcome Measure Information:
Title
Pathological remission of cervical intraepithelial neoplasia
Description
Biopsy, Histopathological examination
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Human papilloma virus remission rate
Description
Smear testing
Time Frame
3-6 months
Title
Comfort / Dyscomfort during intervention
Description
Freiburger Index of patient comfort
Time Frame
Immediately, 2 week, 3-6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Henes, Dr.
Organizational Affiliation
Department for Women's Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Weiss, Dr.
Organizational Affiliation
Department for Women's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Women's Health
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

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