Hemoclin Gel for the Treatment of Hemorrhoids

NCT ID: NCT05124379

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-01-19

Brief Summary

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

Conditions

Hemorrhoids Grade I and II

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemoclin Gel

Group Type: OTHER

Hemoclin Gel

Intervention Type: DEVICE

Non sterile gel for intra-rectal use

Interventions

Hemoclin Gel

Non sterile gel for intra-rectal use

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

11. Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic

12. Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study.

13. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C.

14. Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study.

15. Subject who is currently during home quarantine recommended by the Sanitary Inspection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karo Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"

Gdansk, , Poland

Countries

Poland

Other Identifiers

21E1799/HC_001

Identifier Type: -

Identifier Source: org_study_id