Cervical Intraepithelial NeoplasiaCAPCINNCT03218436
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
A study testing CAP treatment in people with Cervical Intraepithelial Neoplasia, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- CAP treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- CAP treatment
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP treatmentProcedure or surgery
Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
| Study group | Role | What they receive |
|---|---|---|
| CAP cohort | Active comparator | Cold Atmospheric plasma intervention Receives: Procedure: CAP treatment |
| Control cohort | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological remission of cervical intraepithelial neoplasia
Biopsy, Histopathological examination
Measured: 3-6 months
Secondary outcomes (2)
Human papilloma virus remission rate
Smear testing
Measured: 3-6 months
Comfort / Dyscomfort during intervention
Freiburger Index of patient comfort
Measured: Immediately, 2 week, 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Sep 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Henes, Dr., Principal investigator, Department for Women's HealthMartin Weiss, Dr., Principal investigator, Department for Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218436
- Sponsor's protocol ID
- CAP CIN
- Acronym
- CAPCIN
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37654659
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT03218436
- Acronym / sponsor ID
- CAPCIN / CAP CIN
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAP cohort | Active comparator | Procedure: CAP treatmentCold Atmospheric plasma intervention |
| Control cohort | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Histologically confirmed CIN I / II
- Reliable assessment of the radius of the portio and marginal borders of the lesions
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAP treatmentTreatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required. | Procedure or surgery | CAP cohort |
Primary outcome
Pathological remission of cervical intraepithelial neoplasia
Time frame: 3-6 months
Biopsy, Histopathological examination
2 secondary outcomes
Human papilloma virus remission rate
Time frame: 3-6 months
Comfort / Dyscomfort during intervention
Time frame: Immediately, 2 week, 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 37654659Weiss 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.
- doi: 10.3389/fmed.2023.1242732Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Henes, Dr. principal investigator
Department for Women's Health
Martin Weiss, Dr. principal investigator
Department for Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAP treatment in people with Cervical Intraepithelial Neoplasia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological remission of cervical intraepithelial neoplasia (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.