Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

Summary

The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.

The study group comprises 150 primiparous or multiparous women up to 8 weeks after the vaginal (spontaneous or assisted) delivery of singleton, live foetus, in any presentation, in gestational week 34 or more. The timeline for each subject in the study will be up to 5 weeks and will include 3 visits (V1-V3).

All participants will be divided into 3 groups: A, B, C. Group A - subjects with no perineal tear signs, Group B - subjects with grade 1 or 2 per OASIS classification, and Group C - subjects with grade 3 or 4).

The diagnostic performance will be evaluated in comparison to 3-D EUS (endoanal ultrasound) as a primary performance measure (primary endpoint).

Conditions

• Obstetric Anal Sphincter Injury
• Delivery Complication
• Obstetric Complication

Interventions

DIAGNOSTIC_TEST

Laboratory tests: blood and faeces tests

To be performed at V2

DIAGNOSTIC_TEST

Gynaecological and proctological examinations

To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy)

DIAGNOSTIC_TEST

3-D Endoanal Ultrasound

To be performed at V1 (as a reference and for group assignment)

DEVICE

ONIRY measurement

To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured)

DIAGNOSTIC_TEST

High-resolution anorectal manometry

To be performed at V3

DIAGNOSTIC_TEST

ECG

To be performed at V1 and V2 (for safety reasons)

Sponsors & Collaborators

• National Center for Research and Development, Poland

  collaborator OTHER

• OASIS Diagnostics S.A.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2022-12-08

Completion

2022-12-08

Countries

• Czechia
• Poland
• Slovakia
• Spain

Study Locations