NCT05453318

Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Detailed description

The study population consisted of women with a positive Visual Inspection with Acetic Acid (VIA) screening test referred for ablative treatment. A total of 119 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, the patients were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. The women were followed-up at 6 weeks for any complication and re-assessed by colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse event.

Conditions

• Cervical Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Treatment of cervical neoplasia by thermal ablation	Women screened for cervical cancer by VIA presenting lesions eligible for ablative treatment were treated by thermal ablation. The treatment consisted in applying the probe on the lesion for 45 seconds at 100 degrees Celsius, with one to up to five applications depending on the lesion size. Following treatment, women were inquired about the pain level during the procedure, their satisfaction level of the procedure and whether they would recommend this treatment to their relatives. Women had a follow-up visit at 6 weeks to assess any complication of the procedure. Women were rescreened at 12 months, to evaluate the cure rate and any long-term adverse events.

Timeline

• Start date: 2017-10-17
• Primary completion: 2020-08-17
• Completion: 2020-08-17
• First posted: 2022-07-12
• Last updated: 2022-07-12

Locations

1 site across 1 country: Morocco