K64
Conditions
Interventions
Group 1: The medical devices are used in accordance with the manufacturer’s instructions for maximally 30 days.
- Mastu(R) Salbe: The ointment is intended for topical rectal use and is to be applied
Sponsors
Hälsa Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients (= 18 years) with symptomatic haemorrhoids of grade I to III (according to Goligher classification) and a diagnosis made within the last 6 months 2. Sum score of leading haemorrhoidal symptoms (i.e. irritation, itching, burning, discharge) of = 8 (when using a 11-point NRS for the severity assessment of each symptom) 3. Indication for use of Mastu® medical devices, according to the IFU and the investigator’s judgement 4. Willingness, not to use any other prescription and non-prescription medication or medical device for treatment of haemorrhoids during the Post-Market Clinical Follow-up (PMCF) Study 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Septic or severe haemorrhagic complications 2. Known inflammatory bowel disease 3. Similar symptoms in the anal region not caused by haemorrhoids (e.g. anal fissures, anal venous thrombosis, anal eczema, rectal varices caused by portal hypertension, anal or colorectal cancer) 4. Acute diarrhea in the last 12 hours 5. Actual or suspected blood in stool (only if fever and pain are also present) 6. Hypersensitivity to any of the product ingredients 7. Patients not able to follow study procedures, e.g. due to language problems or mental /psychological disorders 8. Any other untoward medical condition that could interfere with the participation of the patient in the trial (e.g. diabetes mellitus; cancer, severe hepatic, renal and/or cardiovascular disease) 9. Patient under Mastu® treatment with more than 14 days during the last 30 days prior to start of the PMCF study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change of mean sum of the severity score of the leading haemorrhoidal symptoms irritation, itching, burning, discharge and blood (Total score 0-50) (day 0, day 14, day 28 (optional)) as assessed by the patient - Evaluation of Safety, tolerability and usability (day 14, day 28 (optionally)) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in skin reddening, presence or absence of epithelial defects/skin erosions, discharge, bleeding and patient burden (day 0, day 14), as assessed by the investigator (Likert scale) - Changes of the severity score of the single haemorrhoidal symptoms: irritation, itching, burning, discharge and bleeding (day 0, day 14, day 28 (optionally)), as assessed by the patient (questionnaire numerical rating scale 0-10) - Changes of pain and bleeding associated with defaecation, as assessed by the patient (day 0, day 7, day 14, day 28 (optionally)) (Questionnaire numerical rating 1-7) - Changes in regard to quality of life and symptom frequency (day 0, day 14, day 28 (optionally), as assessed by the patient - Global assessment of performance by the the investigator (day 14) - Global assessment of performance by the patient (day 14, day 28 (optionally) | — |
Countries
Germany
Contacts
Public ContactKarin Hubel
BioTeSys GmbH
Outcome results
None listed