Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05590520
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter
* symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months.
Exclusion Criteria:
* Patients with acute fissure
* fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer)
* those who had undergone previous surgical procedures in the anal canal.
* known hypersensitivity to component of the formulations of type A BTX
* pregnant or breast-feeding women 6-refusal of consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05590520
Study Brief:
Protocol Section:
NCT05590520