An interventional study of Laboratory tests: blood and faeces tests and Gynaecological and proctological examinations in Obstetric Anal Sphincter Injury, Delivery Complication and Obstetric Complication, sponsored by OASIS Diagnostics S.A.. Completed at 5 sites in 4 countries. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by OASIS Diagnostics S.A. · Not applicable, Interventional, and Diagnostic
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).
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 152 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →OASIS Diagnostics S.A. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):
For group A:
For groups B and C:
Exclusion Criteria:
ONIRY examination
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
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)
Also known as: Impedance spectroscopy measurement
To be performed at V3
To be performed at V1 and V2 (for safety reasons)
Diagnostic Outcome in Clinically-evaluable (CE) Population with 3-D EUS used as the reference diagnostic method
The Diagnostic Outcome defined as Diagnostic Success, Diagnostic Failure or Indeterminate, will be programmatically determined for each subject: a. Diagnostic Success: i. occurrence of an anal sphincter injury; or ii. absence of an anal sphincter injury; confirmed consistently by ONIRY and the reference diagnostic method (True Positive, TP, or True Negative, TN, respectively); b. Diagnostic Failure: i. occurrence of anal sphincter injury detected by ONIRY and absence of anal sphincter injury found out using the reference diagnostic method (False Positive, FP) or ii. absence of anal sphincter injury by ONIRY and occurrence of anal sphincter injury found out using the reference diagnostic method (False Negative, FN); c. Diagnostic Indeterminate - all cases in which no ONIRY or reference diagnostic method result is available or interpretable.
Time frame: Up to 9 weeks post-partum
Diagnostic Outcome in CE Population with physical rectal examination used as the reference diagnostic method
The Diagnostic Outcome defined as Diagnostic Success, Diagnostic Failure or Indeterminate, will be programmatically determined for each subject: a. Diagnostic Success: i. occurrence of an anal sphincter injury; or ii. absence of an anal sphincter injury; confirmed consistently by ONIRY and the reference diagnostic method (True Positive, TP, or True Negative, TN, respectively); b. Diagnostic Failure: i. occurrence of anal sphincter injury detected by ONIRY and absence of anal sphincter injury found out using the reference diagnostic method (False Positive, FP) or ii. absence of anal sphincter injury by ONIRY and occurrence of anal sphincter injury found out using the reference diagnostic method (False Negative, FN); c. Diagnostic Indeterminate - all cases in which no ONIRY or reference diagnostic method result is available or interpretable.
Time frame: Up to 9 weeks post-partum
Diagnostic Outcome in CE Population with high-resolution anorectal manometry used as the reference diagnostic method
The Diagnostic Outcome defined as Diagnostic Success, Diagnostic Failure or Indeterminate, will be programmatically determined for each subject: a. Diagnostic Success: i. occurrence of an anal sphincter injury; or ii. absence of an anal sphincter injury; confirmed consistently by ONIRY and the reference diagnostic method (True Positive, TP, or True Negative, TN, respectively); b. Diagnostic Failure: i. occurrence of anal sphincter injury detected by ONIRY and absence of anal sphincter injury found out using the reference diagnostic method (False Positive, FP) or ii. absence of anal sphincter injury by ONIRY and occurrence of anal sphincter injury found out using the reference diagnostic method (False Negative, FN); c. Diagnostic Indeterminate - all cases in which no ONIRY or reference diagnostic method result is available or interpretable.
Time frame: Up to 13 weeks post-partum
Occurrence of AEs in Safety Population
Assessment of the safety of the device
Time frame: Up to 13 weeks post-partum
Correlation of faecal incontinence symptoms, assessed using Wexner score, with ONIRY, 3-D EUS, physical rectal examination, and high-resolution anorectal manometry results in Safety Population
Exploratory endpoint #1
Time frame: Up to 13 weeks post-partum
Diagnostic Outcome in CE Population with 3-D EUS used as the reference diagnostic method utilising the classification of anal sphincter injuries according to Starck
Exploratory endpoint #2
Time frame: Up to 13 weeks post-partum
Diagnostic Outcome in CE Population with 3-D EUS used as the reference diagnostic method utilising the classification of anal sphincter injuries according to Norderval
Exploratory endpoint #3
Time frame: Up to 13 weeks post-partum
Plan to share: No
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OASIS Diagnostics S.A.