Study Comparing a Newly Designed 4-Blade Device with the Regular Instrument Used During Women s Internal Check-Up

A Comparative Study Between a Traditional Cuscos Vaginal Speculum and The Novel 4 Bladed Vaginal Speculum for Gynecological Examination in Women Attending Saveetha Medical Hospital OPD. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105299

Enrollment

Registered

2026-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: N70-N77- Inflammatory diseases of female pelvic organs

Interventions

Intervention1: 4 bladed vaginal speculum: vaginal insertion during routine gynecological examination or minor gynecological procedures. Control Intervention1: Traditional Cusco s Vaginal Speculum: Sta

Eligibility

Inclusion criteria

Inclusion criteria: Women attending OBG OPD/IPD,Women undergoing gynecological examination,Women undergoing minor gynecological procedures (Copper T removal, endometrial sampling, colposcopy) ,illing to provide informed consent

Exclusion criteria

Exclusion criteria: Unmarried women,Non-consenting women,Vaginal stenosis,Recent pelvic surgery

Design outcomes

Primary

Measure	Time frame
Patient-reported pain score (0 10 scale) during speculum examination.Timepoint: Immediately after examination.	—

Secondary

Measure	Time frame
Patient comfort level (Likert scale),Ease of introduction and removal (time in seconds),Visualization score of cervix,Clinician-reported ease of use Timepoint: Immediately after examination.	—

Countries

India

Contacts

Public ContactDr Varshaa

Saveetha medical college hospital

navinu.smc@saveetha.com9487002379

Outcome results

None listed

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