NCT04181840

Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: OASIS Diagnostics S.A. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. The planned participation of each patient in the study is up to 4 weeks and two visits will take place at that time. After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days. The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter. During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.

Conditions

• Obstetric Anal Sphincter Injury
• Delivery Complication
• Obstetric Complication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood and faeces tests	During V1 - Laboratory tests, particularly for calprotectin concentration assessment
DEVICE	Impedance spectroscopy test	During V1 - the electrical impedance of anal sphincter muscles will be measured
DIAGNOSTIC_TEST	Full gynecological and proctological examination	During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
DIAGNOSTIC_TEST	Transanal ultrasonography	During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
DIAGNOSTIC_TEST	Anorectal manometry	During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
OTHER	Determining the degree of sphincter injury	During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-06-26
• Completion: 2020-07-20
• First posted: 2019-12-02
• Last updated: 2020-09-16

Locations

1 site across 1 country: Poland