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Use of a novel device deescope to ease the routine gynaecological examination as compared to the conventional gynaecological examination

Direct Endoscopic Evaluation of Female Lower Genital Tract: A three pronged approach - DEEscope

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028082
Enrollment
100
Registered
2020-09-28
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: N889- Noninflammatory disorder of cervixuteri, unspecified

Interventions

Intervention1: Direct Endoscopic Evaluation scope: DEEscope: A user friendly, minimally invasive endoscope for vaginal and cervical examination. This Device will help in making a visual diagnosis of v

Sponsors

BIRAC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the married or sexually active women in the age group of 21-65 years willing to participate in the study.

Exclusion criteria

Exclusion criteria: Actively menstruating women and Women who have undergone hysterectomy.

Design outcomes

Primary

MeasureTime frame
To use the device in making a visual diagnosis of various discharges and lesions as well as will allow collecting exfoliative cytology sample for cervical cancer screening in the most optimal way and way and to make gynaecological examination comfortable and easy.Timepoint: Once, after the time of examination with Deescope within an interval of one hour

Secondary

MeasureTime frame
Comparison of ease and efficacy of DeeScope as compared to routine speculum examination â?? in the opinion of ï?® Patient (in terms of comfort) ï?® Gynecologist (in terms of visualization, ergonomics and visual diagnosis ) ï?® Pathologist (yield and ease of cytological diagnosis)Timepoint: Patient and Gynaecologist ease and efficacy shall be measured once at the time of examination within an interval of 1 hour of examination. Ease and efficacy for the pathologist shall be studied once during evaluation of pap smear within 2 weeks of examination.

Countries

India

Contacts

Public ContactRicha Chouksey

KMC, Manipal

jatanavaishnavi247@gmail.com9916657841

Outcome results

None listed

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