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A Comparative Study Of Truscreen vs Pap Smear For Cervical Cancer Screening In General Screening Population

The evaluation of TruScreen Ultra Optical device vs Pap smear for Cervical Screening in General Screening Population: a comparative study

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022650
Enrollment
500
Registered
2020-01-07
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

None listed

Interventions

Control Intervention1: Truscreen Cervical screening system: TruScreen is a novel optoelectronic device, which uses low-level electrical and optical signals to scan the cervix

Sponsors

Khandelwal laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able to understand the conditions of the trial. 2. Willing and able to sign the patient information sheet and consent form.

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 and over the age of 65 years 2.Recent ( 3.Current menstrual period with heavy flow (days 1-3) 4.Known to be pregnant or less than 4 months post-delivery 5.Received surgical treatment to the cervix (including punch biopsies) 6.Previous hysterectomy (corpus and cervix) 7.Receiving experimental photodynamic therapy or otherwise exposed to photosensitive drugs, or suffering from a photosensitising disease (eg, porphyria, lupus erythematous) 8.Has received radiotherapy treatment in the pelvic region at any time previously 9.Receiving chemotherapy, or has received chemotherapy within the last 5 weeks

Design outcomes

Primary

MeasureTime frame
Colposcopy and biopsy outcome o Patient Reported satisfaction rate as compared to PAP smear Timepoint: 3 months, 6 months, 9 months.

Secondary

MeasureTime frame
Patient Reported satisfaction rate as compared to PAP smear Timepoint: 3 months, 6 months, 9 months.

Countries

India

Contacts

Public ContactJAI BHAGWAN SHARMA

All India Institute of Medical Sciences

jbsharma2000@gmail.com9868397309

Outcome results

None listed

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