# Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

> **NCT04903977** · NA · COMPLETED · sponsor: **OASIS Diagnostics S.A.** · enrollment: 152 (actual)

## Conditions studied

- Obstetric Anal Sphincter Injury
- Delivery Complication
- Obstetric Complication

## Interventions

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

## Key facts

- **NCT ID:** NCT04903977
- **Lead sponsor:** OASIS Diagnostics S.A.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-05-20
- **Primary completion:** 2022-12-08
- **Final completion:** 2022-12-08
- **Target enrollment:** 152 (ACTUAL)
- **Last updated:** 2024-01-22

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04903977

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04903977, "Detection of Obstetric Anal Sphincter Injuries With ONIRY Device". Retrieved via AI Analytics 2026-06-22 from https://api.ai-analytics.org/clinical/NCT04903977. Licensed CC0.

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