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Testing of prototype radiofrequency electrode by ablation on excised, discarded cervical tissue

BiRF-C Tissue Ablation Study - BiTS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/015037
Enrollment
20
Registered
2018-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- BiRF-C is a product in research and development. The indication for the product when developed will be cervical dysplasia

Interventions

None listed

Sponsors

India Medtronic Pvt Ltd
Lead Sponsor
Medtronic Surgical Innovations
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 20-60 years of age Patients undergoing total or radical hysterectomy due to non-malignant disease, during routine clinical care. The subject or her Legally Authorized Representative (LAR) has been informed about the nature of the study and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements Study team able to test discarded excised tissues within 5 hours after hysterectomy

Exclusion criteria

Exclusion criteria: Malignancy/cancerous tissue in the uterus Not willing to consent

Design outcomes

Primary

MeasureTime frame
Ablation depthTimepoint: Within five hours of hysterectomy performed as per routine clinical care

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactVinay Rajan

Regional Clinical Indian Subcontinent

vinay.rajan@medtronic.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026