Obstetric Anal Sphincter InjuryNCT04903977
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
A study testing Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations and 3-D Endoanal Ultrasound in people with Obstetric Anal Sphincter Injury and Delivery Complication, run by OASIS Diagnostics S.A. at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- What is being tested?
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations and 3-D Endoanal Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 20 May 2021to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 49 years old;
- Primiparous or multiparous;
- Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):
- of singleton, live foetus,
- in any presentation,
- in gestational week 34 or more.
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- For group A:
- no clinical signs of any degree perineal tear
- no clinical signs or symptoms of any damage involving anal sphincters;
- 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
- For groups B and C:
- clinically confirmed 1 or 2-degree perineal tear (including episiotomy and uncontrolled crotch rupture) occurred at the last delivery (for group B);
- clinically identified 3 or 4-degree perineal tear (damage involving anal sphincters) occurred at the last delivery (regardless of primary repair) (for group C);
- Signed informed consent form (no proxy or witnessed consent allowed).
Who cannot join
- Any acute, uncontrolled disease (except for haemorrhoidal disease)
- Chronic diseases not treated or not stable on treatment;
- Symptoms of faecal incontinence due to a disease other than diagnosed or suspected OASIS;
- 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);
- Any surgery in perineal or rectal area, including surgery for OASIS, planned for the study period
- Presence of inflammatory bowel diseases during exacerbation phase;
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- 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,
- Disease other than OASIS so far undiagnosed and reported during the visit V1 or within 7 days prior to it;
- Present or suspected malignancy or previous oncological treatment in the last 5 years;
- Implanted cardiac stimulator or cardioverter-defibrillator;
- Clinically significant cardiac arrhythmias observed in ECG examination or reported in history for the last 12 months;
- Fever (>37°C) at enrolment;
- History of major surgery in perineal or rectal area (other than for OASIS) or severe trauma of perineum or rectum.
- 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).
- 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).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Czechia2 sites
Fakultni nemocnice
Brno, 625 00
Ustav pro peci o matku a dite
Prague, 147 10
Poland1 site
FEMINITY Praktyka Lekarska dr Małgorzata Uchman-Musielak
Warsaw, 05-077
Slovakia1 site
Gynekologicko-pôrodnícka klinika Nemocnica AGEL Košice-Šaca a.s.
Košice, Košice Region, 040 15
About this study
Official title: Clinical Performance and Safety of ONIRY Device in Detecting Obstetric Anal Sphincter Injuries Using Machine-learning-assisted Impedance Spectroscopy
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).
Read more
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).
Read the 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.
- Being tested
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound, ONIRY measurement, High-resolution anorectal manometry
- Keywords
- impedance spectroscopy, ONIRY, machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tests: blood and faeces testsDiagnostic test
To be performed at V2
Gynaecological and proctological examinationsDiagnostic test
To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy)
3-D Endoanal UltrasoundDiagnostic test
To be performed at V1 (as a reference and for group assignment)
ONIRY measurementDevice
Also called Impedance spectroscopy measurement
To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured)
High-resolution anorectal manometryDiagnostic test
To be performed at V3
ECGDiagnostic test
To be performed at V1 and V2 (for safety reasons)
| Study group | Role | What they receive |
|---|---|---|
| Impedance spectroscopy | Experimental | ONIRY examination Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Up to 9 weeks post-partum
Secondary outcomes (3)
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:
- 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.
Measured: 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:
- 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.
Measured: Up to 13 weeks post-partum
Occurrence of AEs in Safety Population
Assessment of the safety of the device
Measured: Up to 13 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start20 May 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- OASIS Diagnostics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903977
- Sponsor's protocol ID
- 3/2/2020 AMD 02, Sep 16, 2022
- Status last verified
- Jan 2024
- First submitted
- 17 May 2021
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Safety of ONIRY Device in Detecting Obstetric Anal Sphincter Injuries Using Machine-learning-assisted Impedance Spectroscopy
- ClinicalTrials.gov ID
- NCT04903977
- Acronym / sponsor ID
- 3/2/2020 AMD 02, Sep 16, 2022
- Keywords
- impedance spectroscopy, ONIRY, machine learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- OASIS Diagnostics S.A.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 20 May 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impedance spectroscopy | Experimental | 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: ECGONIRY examination |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Women between 18 and 49 years old;
- Primiparous or multiparous;
- Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):
- For group A:
- For groups B and C:
Key exclusion criteria (15 listed)
- Any acute, uncontrolled disease (except for haemorrhoidal disease)
- Chronic diseases not treated or not stable on treatment;
- Symptoms of faecal incontinence due to a disease other than diagnosed or suspected OASIS;
- 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);
- Any surgery in perineal or rectal area, including surgery for OASIS, planned for the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tests: blood and faeces testsTo be performed at V2 | Diagnostic test | Impedance spectroscopy |
| Gynaecological and proctological examinationsTo be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy) | Diagnostic test | Impedance spectroscopy |
| 3-D Endoanal UltrasoundTo be performed at V1 (as a reference and for group assignment) | Diagnostic test | Impedance spectroscopy |
| ONIRY measurementAlso: Impedance spectroscopy measurementTo be performed at V2 (the electrical impedance of anal sphincter muscles will be measured) | Device | Impedance spectroscopy |
| High-resolution anorectal manometryTo be performed at V3 | Diagnostic test | Impedance spectroscopy |
| ECGTo be performed at V1 and V2 (for safety reasons) | Diagnostic test | Impedance spectroscopy |
Primary outcome
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.
3 secondary outcomes
Diagnostic Outcome in CE Population with physical rectal examination used as the reference diagnostic method
Time frame: Up to 9 weeks post-partum
Diagnostic Outcome in CE Population with high-resolution anorectal manometry used as the reference diagnostic method
Time frame: Up to 13 weeks post-partum
Occurrence of AEs in Safety Population
Time frame: Up to 13 weeks post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations and 3-D Endoanal Ultrasound in people with Obstetric Anal Sphincter Injury and Delivery Complication, run by OASIS Diagnostics S.A. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Poland, Slovakia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.