Hemoclin Gel for the Treatment of Hemorrhoids

Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.

NCT05124379•Karo Pharma AB

Summary

Post market, single arm, clinical investigation to assess safety and performance of the product.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

•1. Healthy subjects.
•2. Sex: male or female.
•3. Age: more than 18 years old.
•4. Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
•5. Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
•6. Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
•7. Able and willing to provide informed consent and comply with study procedures

•1. Pregnant or nursing woman or planning a pregnancy during the study.
•2. Subject not able or not willing to provide informed consent and comply with study procedures
•3. Subject who had been deprived of their freedom by administrative or legal decision.
•4. Major subject who is under guardianship or who is not able to express his consent.
•5. Subject in a social or sanitary establishment.
•6. Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
•7. Grade III or IV haemorrhoids (Goligher classification).
•8. Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections.
•9. Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
•10. Any anal topical medication applied in last 7 days.
+5 more criteria

Locations (1)

GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"

Gdansk, Poland

Key Dates

Start Date

November 1, 2021

Primary Completion Date

November 17, 2021

Completion Date

January 19, 2022

Last Updated

March 31, 2022

Enrollment

ACTUAL participants

Conditions

Hemorrhoids Grade I and II

Interventions

Hemoclin Gel

DEVICE