Cervical Intraepithelial Neoplasia IIIZGynO_CINIIINCT04753073
Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma
A study testing Non-invasive physical plasma in people with Cervical Intraepithelial Neoplasia III, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions. The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia III
- What is being tested?
- Non-invasive physical plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 30 Jun 2024
- 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
- Age ≥ 18 years
- Histologically confirmed CIN III
- Clearly visible transformation zone of the portio and margins of the lesions according to T1 / T2
- signed written consent
Who cannot join
- Not fully visible transformation zone
- Indication of an invasive disease
- Serious cardiovascular diseases
- Patients who only want to undergo a LEEP excision
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
About this study
The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.
- The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision.
- Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.
Read the detailed description
Cervical intraepithelial neoplasms (CIN), classified into severity levels CIN I to III, can be precursors to cervical cancer (CC), the world's third most common cancer in women (270,000 deaths / year), which radical therapies are often associated with lifelong severe physical and emotional stress. Cross-sectional studies found a prevalence for CIN of 62 per 1,000 women and incidences of 1.2 (CIN I), 0.8 (CIN II) and 0.7 (CIN III) per 1,000 women per year (highest incidence of CIN between 20 and 24 years) age). The standard therapy for the treatment of CIN III by LEEP excision is associated with an increase in mortality of 17%. CIN III, in particular, is associated with a significant decline in quality of life, psychological well-being and sexual health, although on average only about 12% of CIN III lesions progress to invasive CC. The resulting over-treatment (in around 8-9 out of 10 patients) with invasive procedures is a serious problem for affected women, health care providers and the health economy.
The NIPP treatment is a tissue-sparing, pain-free, easy to carry out and outpatient treatment method without anesthesia and hospitalization. A non-randomized, one-arm feasibility study at the Department of Women's Health (649 / 2017BO1) already showed the effectiveness of a NIPP treatment.
Clinical implications for CIN III:
- A previous NIPP treatment should significantly reduce the invasiveness of the LEEP excision.
- If the oncological safety of NIPP treatment is comparable (histological complete remission of CIN III), NIPP is to be established as a safe alternative to LEEP excision in the future.
- Conditions
- Cervical Intraepithelial Neoplasia III
- Being tested
- Non-invasive physical plasma
- 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.
Non-invasive physical plasmaProcedure or surgery
Treatment with non invasive physical low-temperature plasma
| Study group | Role | What they receive |
|---|---|---|
| NIPP | Experimental | Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision Receives: Procedure: Non-invasive physical plasma |
| Controll | No intervention | LEEP-Exzision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of histological complete remission
Rate of histological complete remission of the CIN III at the time of the LEEP excision
Measured: 8 Weeks
Secondary outcomes (3)
Rate of partial histological remission
Rate of partial histological remission of the CIN I / II
Measured: 8 Weeks
Rate of decreased HPV viral load
Rate of decreased HPV viral load in tissues
Measured: 8 Weeks
Pain and quality of life
Pain and quality of life (Freiburg index for patient satisfaction)
- Pain assessment i) previous to, ii) during, iii) 4 h after, iv) 2 days after, v) 1 week after NIPP treatment, min/max values: 0 - 10, higher scores mean worse outcome
- Satisfaction assessment, min/max values: 1-6, higher scores mean worse outcome
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 Neoplasia IIIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Weiss, Dr. med.q, Principal investigator, Department of Women's Health, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753073
- Sponsor's protocol ID
- ZGynO_CIN_III
- Acronym
- ZGynO_CINIII
- Status last verified
- Jul 2024
- First submitted
- 2 Feb 2021
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henes M, Matovina S, Rottscholl R, Feng YS, Fleischhacker A, Wang G, Enderle M, Awakowicz P, Brucker SY, Weiss M. Tissue preserving non-invasive physical plasma treatment for cervical squamous intraepithelial neoplasia grade 3-a prospective randomized, controlled clinical trial. Front Med (Lausanne). 2025 Nov 7;12:1669933. doi: 10.3389/fmed.2025.1669933. eCollection 2025.
PubMed 41282018
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma
- ClinicalTrials.gov ID
- NCT04753073
- Acronym / sponsor ID
- ZGynO_CINIII / ZGynO_CIN_III
- Conditions
- Cervical Intraepithelial Neoplasia III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Feb 2021 (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.
The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.
- The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision.
- Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.
Detailed description
Cervical intraepithelial neoplasms (CIN), classified into severity levels CIN I to III, can be precursors to cervical cancer (CC), the world's third most common cancer in women (270,000 deaths / year), which radical therapies are often associated with lifelong severe physical and emotional stress. Cross-sectional studies found a prevalence for CIN of 62 per 1,000 women and incidences of 1.2 (CIN I), 0.8 (CIN II) and 0.7 (CIN III) per 1,000 women per year (highest incidence of CIN between 20 and 24 years) age). The standard therapy for the treatment of CIN III by LEEP excision is associated with an increase in mortality of 17%. CIN III, in particular, is associated with a significant decline in quality of life, psychological well-being and sexual health, although on average only about 12% of CIN III lesions progress to invasive CC. The resulting over-treatment (in around 8-9 out of 10 patients) with invasive procedures is a serious problem for affected women, health care providers and the health economy.
The NIPP treatment is a tissue-sparing, pain-free, easy to carry out and outpatient treatment method without anesthesia and hospitalization. A non-randomized, one-arm feasibility study at the Department of Women's Health (649 / 2017BO1) already showed the effectiveness of a NIPP treatment.
Clinical implications for CIN III:
- A previous NIPP treatment should significantly reduce the invasiveness of the LEEP excision.
- If the oncological safety of NIPP treatment is comparable (histological complete remission of CIN III), NIPP is to be established as a safe alternative to LEEP excision in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPP | Experimental | Procedure: Non-invasive physical plasmaTreatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision |
| Controll | No intervention | –LEEP-Exzision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Not fully visible transformation zone
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 |
|---|---|---|
| Non-invasive physical plasmaTreatment with non invasive physical low-temperature plasma | Procedure or surgery | NIPP |
Primary outcome
Rate of histological complete remission
Time frame: 8 Weeks
Rate of histological complete remission of the CIN III at the time of the LEEP excision
3 secondary outcomes
Rate of partial histological remission
Time frame: 8 Weeks
Rate of decreased HPV viral load
Time frame: 8 Weeks
Pain and quality of life
Time frame: 8 Weeks
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 5 Jul 2024.
- Derived from this study: PubMed 41282018Henes M, Matovina S, Rottscholl R, Feng YS, Fleischhacker A, Wang G, Enderle M, Awakowicz P, Brucker SY, Weiss M. Tissue preserving non-invasive physical plasma treatment for cervical squamous intraepithelial neoplasia grade 3-a prospective randomized, controlled clinical trial. Front Med (Lausanne). 2025 Nov 7;12:1669933. doi: 10.3389/fmed.2025.1669933. eCollection 2025.
- 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.
Martin Weiss, Dr. med.q principal investigator
Department of Women's Health, University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive physical plasma in people with Cervical Intraepithelial Neoplasia III, 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 4 inclusion and 4 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 5 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?
Rate of histological complete remission (time frame: 8 Weeks). 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 NCT04753073, 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 5 Jul 2024.