Post market, single arm, clinical investigation to assess safety and performance of the product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Non sterile gel for intra-rectal use
GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"
Gdansk, Poland
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
Severity of itch will be evaluated by the patient with a 6 point structured scale.
Time frame: 2 weeks
To evaluate by the patient the efficacy of tested product on the severity of bleeding
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time frame: 2 weeks
To evaluate by the patient the efficacy of tested product on the sense of discomfort
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time frame: 2 weeks
To evaluate the overall satisfaction of the patient according to
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time frame: 2 weeks
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time frame: 2 weeks
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