NCT04903977

Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

Completed NA Last updated 22 January 2024

What this trial tests

NA trial testing Laboratory tests: blood and faeces tests in Obstetric Anal Sphincter Injury in 152 participants. Completed in 8 December 2022.

Timeline

20 May 2021

Primary endpoint
8 December 2022

8 December 2022

Quick facts

Lead sponsor	OASIS Diagnostics S.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	152
Start date	20 May 2021
Primary completion	8 December 2022
Estimated completion	8 December 2022
Sites	5 locations across Spain, Slovakia, Poland, Czechia

Drugs / interventions tested

• Laboratory tests: blood and faeces tests
• Gynaecological and proctological examinations
• 3-D Endoanal Ultrasound
• ONIRY measurement
• High-resolution anorectal manometry
• ECG

Conditions studied

• Obstetric Anal Sphincter Injury — all drugs for Obstetric Anal Sphincter Injury →
• Delivery Complication — all drugs for Delivery Complication →
• Obstetric Complication — all drugs for Obstetric Complication →

Sponsor

OASIS Diagnostics S.A.

Who can join

Adults 18 to 49, female only, with Obstetric Anal Sphincter Injury or Delivery Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Detection of obstetric anal sphincter injuries using machine learning-assisted impedance spectroscopy: a prospective, comparative, multicentre clinical study.
   Borycka K, Młyńczak M, Rosoł M, Korzeniewski K, et al · · 2025 · cited 4× · PMID 40033085 · DOI 10.1038/s41598-025-92392-z
2. Diagnostic accuracy of Impedance Spectroscopy versus Digital Rectal Examination for Obstetric Anal Sphincter Injuries: a postpartum post-hoc analysis
   Salvatore S, Borycka K, Ruffolo A, Młyńczak M, et al · · 2024 · DOI 10.1101/2024.09.18.24313868