FindTrial
Sign In

A new technique of hysteroscopy using alginate gel interface for obliteration of introitus versus the standard no-touch vaginoscopic hysteroscopy by manual closure

A novel technique of vagino-hysteroscopy using Alginate Gel Interface: a proof of concept study - VAGI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023866
Enrollment
100
Registered
2020-03-09
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: N939- Abnormal uterine and vaginal bleeding, unspecified Health Condition 2: N91- Absent, scanty and rare menstruation Health Condition 3: N92- Excessive, frequent and irregularmenstruation Health Condition 4: N97- Female infertility Health Condition 5: N84- Polyp of female genital tract Health Condition 6: N950- Postmenopausal bleeding Health Condition 7: N949- Unspecified condition associated with female genital organs and menstrual cycle

Interventions

Intervention1: VAGINOSCOPIC HYSTEROSCOPY BY ALGINATE GEL INTERFACE: vaginoscopic no-touch hysteroscopy will be done using Alginate Gel Interface for vaginal occlusion Control Intervention1: CONVENTION

Sponsors

UCMS AND GTB HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Sexually active women of all age groups requiring hysteroscopy for any gynecological indication

Exclusion criteria

Exclusion criteria: Pregnancy Active vaginal bleeding Active genital infection Cervical Cancer History of medical disorder such as hepatic or renal disease, ischemic heart disease etc

Design outcomes

Primary

MeasureTime frame
FeasibilityTimepoint: intra-operatively after successful visualisation of uterine cavity—

Secondary

MeasureTime frame
Feasibility with respect to patient factorsTimepoint: Intra-operatively;Fluid spillageTimepoint: Immediate post procedure;Hydrostatic pressure required for optimal visualizationTimepoint: at vagina, cervix, uterus;Intra-operative complicationsTimepoint: Intra-operatively;Maneuverability on Likert ScaleTimepoint: immediate post procedure;Pain experienced by patient during procedure on Visual Analogue ScaleTimepoint: Immediate post procedure;Post-operative complicationsTimepoint: after 1 week;Surgeon satisfaction rated on Likert ScaleTimepoint: Immediate post procedure;Total irrigation fluidTimepoint: Immediate post procedure;Total operative timeTimepoint: from start of procedure till visualization of uterine cavity—

Countries

India

Contacts

Public ContactKANIKA KALRA

UCMS AND GTB HOSPITAL, DILSHAD GAREN, DELHI

drsandy2015@gmail.com

Outcome results

None listed

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