49
Participants
Start Date
October 15, 2019
Primary Completion Date
June 26, 2020
Study Completion Date
July 20, 2020
Blood and faeces tests
During V1 - Laboratory tests, particularly for calprotectin concentration assessment
Impedance spectroscopy test
During V1 - the electrical impedance of anal sphincter muscles will be measured
Full gynecological and proctological examination
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
Transanal ultrasonography
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Anorectal manometry
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
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.
Praktyka Lekarska Małgorzata Uchman-Musielak, Warsaw
Lead Sponsor
OASIS Diagnostics S.A.
INDUSTRY