Clinical trials: Obstetric Anal Sphincter Injury
Obstetric Anal Sphincter Injury, Delivery, Obstetric
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective.
- Trial name
- NCT03769792
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- OASIS Diagnostics S.A.
Obstetric Anal Sphincter Injury, Delivery Complication
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
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.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04903977
- Testing
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound
- Where
- 5 sites in Czechia, Poland and 2 more
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- OASIS Diagnostics S.A.
Fecal Incontinence
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal…
- Trial name
- DigniFI (NCT05776277)
- Testing
- Iltamiocel
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook MyoSite
Obstetric Anal Sphincter Injury, Delivery Complication
Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
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.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04181840
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 49 people
- Sponsor
- OASIS Diagnostics S.A.