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Post market, single arm, clinical investigation to assess safety and performance of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoclin Gel | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoclin Gel | Device | Non sterile gel for intra-rectal use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| To evaluate by the patient the efficacy of tested product on the sense of discomfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GastroDent Gabinet Gastroenterologiczny z PracowniÄ… EndoskopowÄ…" | Gdansk | Poland |
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Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant. |
| 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. | 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. | 2 weeks |