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Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

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ClinicalTrials.gov Identifier: NCT04903977
Recruitment Status : Not yet recruiting
First Posted : May 27, 2021
Last Update Posted : May 27, 2021
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
OASIS Diagnostics S.A.

Tracking Information
First Submitted Date  ICMJE May 17, 2021
First Posted Date  ICMJE May 27, 2021
Last Update Posted Date May 27, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2021)
Diagnostic Outcome in Clinically-evaluable (CE) Population with 3-D EUS used as the reference diagnostic method [ Time Frame: Up to 9 weeks post-partum ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2021)
  • Diagnostic Outcome in CE Population with physical rectal examination used as the reference diagnostic method [ Time Frame: Up to 9 weeks post-partum ]
    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.
  • Diagnostic Outcome in CE Population with high-resolution anorectal manometry used as the reference diagnostic method [ Time Frame: Up to 13 weeks post-partum ]
    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.
  • Occurrence of AEs in Safety Population [ Time Frame: Up to 13 weeks post-partum ]
    Assessment of the safety of the device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2021)
  • 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 [ Time Frame: Up to 13 weeks post-partum ]
    Exploratory endpoint #1
  • 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 [ Time Frame: Up to 13 weeks post-partum ]
    Exploratory endpoint #2
  • 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 [ Time Frame: Up to 13 weeks post-partum ]
    Exploratory endpoint #3
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
Official Title  ICMJE Clinical Performance and Safety of ONIRY Device in Detecting Obstetric Anal Sphincter Injuries Using Machine-learning-assisted Impedance Spectroscopy
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Obstetric Anal Sphincter Injury
  • Delivery Complication
  • Obstetric Complication
Intervention  ICMJE
  • 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)
    Other Name: Impedance spectroscopy measurement
  • Diagnostic Test: High-resolution anorectal manometry
    To be performed at V3
  • Diagnostic Test: ECG
    To be performed at V1 and V2 (for safety reasons)
Study Arms  ICMJE Experimental: Impedance spectroscopy
ONIRY examination
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women between 18 and 49 years old;
  2. Primiparous or multiparous;
  3. Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):

    1. of singleton, live foetus,
    2. in any presentation,
    3. in gestational week 34 or more.
  4. For group A:

    1. no clinical signs of any degree perineal tear
    2. no clinical signs or symptoms of any damage involving anal sphincters;
    3. presence of not more than 1 of following OASIS risk factors related to the last delivery: prolonged second phase of delivery, foetal shoulder dystocia, birth weight of the neonate >4kg, induction of delivery using oxytocin, or head circumference of the neonate ≥34 cm
  5. For groups B and C:

    1. clinically confirmed 1 or 2-degree perineal tear (including episiotomy and uncontrolled crotch rupture) occurred at the last delivery (for group B);
    2. clinically identified 3 or 4-degree perineal tear (damage involving anal sphincters) occurred at the last delivery (regardless of primary repair) (for group C);
  6. Signed informed consent form (no proxy or witnessed consent allowed).

Exclusion Criteria:

  1. Any acute, uncontrolled disease (except for haemorrhoidal disease)
  2. Chronic diseases not treated or not stable on treatment;
  3. Symptoms of faecal incontinence due to a disease other than diagnosed or suspected OASIS;
  4. Previous surgery for OASIS (primary or secondary), faecal incontinence or anal prolapse, except for a primary repair of anal sphincter damage performed after the last delivery (allowed);
  5. Any surgery in perineal or rectal area, including surgery for OASIS, planned for the study period
  6. Presence of inflammatory bowel diseases during exacerbation phase;
  7. Any treatment during last 12 months for severe, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness that could increase subject's risk due to participation in the study,
  8. Disease other than OASIS so far undiagnosed and reported during the visit V1 or within 7 days prior to it;
  9. Present or suspected malignancy or previous oncological treatment in the last 5 years;
  10. Implanted cardiac stimulator or cardioverter-defibrillator;
  11. Clinically significant cardiac arrhythmias observed in ECG examination or reported in history for the last 12 months;
  12. Fever (>37°C) at enrolment;
  13. History of major surgery in perineal or rectal area (other than for OASIS) or severe trauma of perineum or rectum.
  14. Use, or need for use, of an anal suppository or other anally administered drug, or cosmetic for the perianal area, within 12 hours prior to impedance spectroscopy examination (visit V2).
  15. Positive pregnancy test (only for subjects recruited ≥4 weeks after delivery with no lactation at V1 visit; however, subjects with a positive pregnancy test may be enrolled as long as gynaecologic ultrasound performed at V1 visit shows no signs of a new pregnancy, no sings suggestive of placental tissue remaining in utero, or other abnormality of the uterus).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Katarzyna Borycka, MD, PhD +48 502 733 961 katarzyna.borycka@oasis-diagnostics.eu
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04903977
Other Study ID Numbers  ICMJE 3/2/2020 version 1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OASIS Diagnostics S.A.
Study Sponsor  ICMJE OASIS Diagnostics S.A.
Collaborators  ICMJE National Center for Research and Development, Poland
Investigators  ICMJE Not Provided
PRS Account OASIS Diagnostics S.A.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP