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| Name | Class |
|---|---|
| University of North Carolina Global Project Zambia | UNKNOWN |
| Liger Medical Llc | UNKNOWN |
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This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.
This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are
In collaboration with a medical devices company in Utah, the engineering performance of the Liger Thermal Coagulator has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermocoagulation (device) | Experimental | VIA Positive women will be treated by the new device for thermocoagulation |
|
| Cryotherapy (device) | Active Comparator | VIA positive women will be treated by cryotherapy |
|
| LEEP (device) | Active Comparator | VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermocoagulation (device) | Procedure | Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline | The VIA positive women will be followed up after 12 months to see if the lesions have disappeared. HPV test will be used as the test of cure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens | The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Partha Basu, Dr | IARC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Global Project Zambia | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31734069 | Background | Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14. | |
| 34197624 | Background | Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31. |
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| Cryotherapy (device) | Procedure | Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix |
|
| LEEP (device) | Procedure | The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit |
|
| 38918630 | Background | Basu P, Mwanahamuntu M, Pinder LF, Muwonge R, Lucas E, Nyambe N, Chisele S, Shibemba AL, Sauvaget C, Sankaranarayanan R, Prendiville W, Parham GP. A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial. Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25. |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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