Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
Condition: Obstetric Anal Sphincter Injury; Delivery Complication; Obstetric Complication
MeSH terms: Wounds and Injuries
Study type: Interventional

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).
    

Detailed 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 whole study is divided into 2 parts. Part I is a clinical trial;
      after completion of Part I, an analytical classification model will be established (during
      Part II) based on data from pilot studies and Part I of the study. It will be then built into
      the ONIRY Meter as a machine-learning-based interpretation module; proposed for ultimate
      marketing authorisation.

      Part I of the study will be prospective, multicentre, international. 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).

      After obtaining written consent, at the first study visit (V1) each patient will undergo a
      general physical examination, proctological and gynaecological examination, ECG recording,
      3-D EUS (endoanal ultrasound, used as a reference and for the study group allocation) and
      once V1 visit is conducted 3 or more days after delivery Wexner score will be used to assess
      the clinical symptoms of faecal incontinence.

      Based on the physical proctological examination and EUS at the V1 visit, all participants
      will be divided into 3 groups: A, B, C. Group A - subjects with no perineal tear signs, Group
      B - subjects with the presence of perineal skin injury or perineum injury involving crotch
      muscles but not involving anal sphincters (grade 1 or 2 per OASIS classification) and Group C
      - subjects with the presence of perineal injury involving anal sphincters (damage of the
      external anal sphincter thickness, damage to both the external and internal anal sphincters,
      or damage to the perineum, anal sphincteric complex and anal epithelium; grade 3-4).

      On the visit V2 performed on the same day as V1 or scheduled up to 7 days after the V1, after
      the final verification of inclusion/exclusion criteria, blood samples for laboratory tests
      and stool samples for calprotectin concentration assessment will be collected, ONIRY
      recording will be made, 10 minutes after the end of the impedance measurement 12-lead ECG
      recording will also be performed in each patient.

      On the third visit (V3) 1-28 days after visit V2, high-resolution Anorectal Manometry will be
      conducted.

      No control group is planned. However, study participants will be controls for themselves
      (test and reference diagnostic methods will be applied and evaluated in each subject).

      In Part I of the study, the ONIRY system will provide only preliminary interpretations of the
      impedance measurements based on models established from the data collected during Pilot
      Studies No. 1/1/2018 (NCT03769792) and No. 2/1/2019 (NCT04181840). The web-based app will be
      used to provide the interpretations.
    

Intervention name(s): Laboratory tests: blood and faeces tests; Gynaecological and proctological examinations; 3-D Endoanal Ultrasound; ONIRY measurement; High-resolution anorectal manometry; ECG
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Device; Diagnostic Test; Diagnostic Test
Intervention description(s): To be performed at V2; To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy); To be performed at V1 (as a reference and for group assignment); To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured); To be performed at V3; To be performed at V1 and V2 (for safety reasons)
Other intervention name(s): Impedance spectroscopy measurement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: impedance spectroscopy; ONIRY; machine learning