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The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIPP | Experimental | Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision |
|
| Controll | No Intervention | LEEP-Exzision |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive physical plasma | Procedure | Treatment with non invasive physical low-temperature plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of histological complete remission | Rate of histological complete remission of the CIN III at the time of the LEEP excision | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of partial histological remission | Rate of partial histological remission of the CIN I / II | 8 Weeks |
| Rate of decreased HPV viral load | Rate of decreased HPV viral load in tissues |
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Inclusion Criteria:
Age ≥ 18 years
Exclusion Criteria:
Not fully visible transformation zone
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| Name | Affiliation | Role |
|---|---|---|
| Martin Weiss, Dr. med.q | Department of Women's Health, University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen, Department of Women's Health | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41282018 | Derived | 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. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| 8 Weeks |
| Pain and quality of life | Pain and quality of life (Freiburg index for patient satisfaction)
| 8 Weeks |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |