Physical Cold Atmospheric Plasma for the Treatment of Cer... | NCT03218436

Studies
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

NCT03218436

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 23, 2024Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Cervical Intraepithelial Neoplasia

Interventions

CAP treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Jul 13, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2024

Last Update Posted Date

Jul 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAP cohort	Active Comparator	Cold Atmospheric plasma intervention	Procedure: CAP treatment
Control cohort	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAP treatment	Procedure	Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.	CAP cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melanie Henes, Dr.	Department for Women's Health	Principal Investigator
Martin Weiss, Dr.	Department for Women's Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Women's Health		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37654659	Derived	Weiss M, Arnholdt M, Hissnauer A, Fischer I, Schonfisch B, Andress J, Gerstner S, Dannehl D, Bosmuller H, Staebler A, Brucker SY, Henes M. Tissue-preserving treatment with non-invasive physical plasma of cervical intraepithelial neoplasia-a prospective controlled clinical trial. Front Med (Lausanne). 2023 Aug 15;10:1242732. doi: 10.3389/fmed.2023.1242732. eCollection 2023.

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases