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This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification) haemorrhoids as assessed by the patient and the Investigator at the end of the treatment period.
The protocol is based on what is already known on both the topic object of the study, i.e., the symptomatic treatment of haemorrhoids, and the investigational medical device - PROCTOeze® PLUS - which is a specific adjuvant for the symptomatic relief of internal and external haemorrhoids and anal irritation. Due to its formulation, it contributes to the physiological restoration of the anal and perianal tissues.
The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyse, the data needed to study the relationships between different variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROCTOeze® PLUS | Experimental | Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrophilic emulsion for the relief of haemorroidal symptoms | Device | Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) | The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). Is an instrument with just 1 question in each of its 4 dimensions, including symptom burden, functional status, disease-specific worries, and general well-being measured according to A 7-point Likert scale to be summed giving a total score ranging from 4 to 28. The total of the four dimensions has been analyzed. The unit of measure is "score". SHS was adapted for HD (Short Health Scale for Haemorrhoidal Disease - SHSHD) in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines; SHSHD has shown to be a reliable and responsive measure for HRQoL. | From enrollment to the end of treatment on day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician | HSS is a physician-reported measurement instrument based on PNR-Bleed classification. All four components in this classification system are graded into five grades ranging from 1 to 5. Grade 1 is the normal anal cushions and Grade 5 is the worst grade in a specific characteristic. HSS is the total score obtained by the sum of the numerical grades of all four characteristics of haemorrhoids in the PNR-Bleed classification. The minimum HSS score is 4 and the maximum score can be 20. The HSS score of a normal person without any signs and symptoms of haemorrhoids is 4. Calculation of the HSS helps in the quantification of the haemorrhoidal disease for further reference and is helpful in post-treatment patient follow-up to grade the response to treatment and to assess the effectiveness or failure of any particular treatment regimen for haemorrhoids. The total of the four dimensions has been analyzed. The unit of measure is "score". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Cristina Sisu, Dr. | CMI Dr Sisu Lucia Cristina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.M.I. Sisu Lucia Cristina | Craiova | Dolj | Romania |
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Start of enrolment (FPI) 5th November 2024; End of enrolment (LPI) 17th December 2024; End of treatment (LPO) 17th January 2025.
Recruitment in the ambulatory of a General Physician office.
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| ID | Title | Description |
|---|---|---|
| FG000 | PROCTOeze® PLUS | Single arm, adults. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult patients affected by Grade I-II (Goligher classification) haemorrhoids that did not need hospitalization and treated as outpatients (the treatment will be self-administered at home).
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| ID | Title | Description |
|---|---|---|
| BG000 | PROCTOeze® PLUS | Single arm, adults. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) | The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). Is an instrument with just 1 question in each of its 4 dimensions, including symptom burden, functional status, disease-specific worries, and general well-being measured according to A 7-point Likert scale to be summed giving a total score ranging from 4 to 28. The total of the four dimensions has been analyzed. The unit of measure is "score". SHS was adapted for HD (Short Health Scale for Haemorrhoidal Disease - SHSHD) in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines; SHSHD has shown to be a reliable and responsive measure for HRQoL. | Posted | Mean | Standard Deviation | Score | From enrollment to the end of treatment on day 14. |
|
From enrollment up to end of follow-up, up to 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PROCTOeze® PLUS | Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology. |
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This study has no limitations since there are no drop-out patients and the symptoms measurements were performed with objective, widely-accepted and validated scales.
In addition, treatment compliance was optimal according to the patient diary, which was filled in daily during the treatment period by all participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donatella Mariani | Biokosmes Srl | +41 79 844 2600 | d.mariani@solarishc.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 13, 2025 | Aug 1, 2025 | Prot_SAP_ICF_000.pdf |
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| From enrollment to the end of treatment on day 14. |
| Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient | The Haemorrhoidal Disease Symptom Score (HDSS), a patient-reported outcome questionnaire, will be administered by Investigator to each patient at baseline and at day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 5, where lower grades are better, with a total of 5 items on the questionnaire. The HDSS is a patient-reported measurement instrument. It comprises five items. Symptoms are assessed using the patient-reported frequency of the 5 symptoms, including pain, itching, bleeding, soiling, and prolapse. Patients are instructed to answer based on their experience during the previous period. Each symptom is graded on a 5-point scale (0 = never, 1 = less than once a month, 2 = less than once a week, 3 = 1-6 days per week, 4 = every day or always), giving a total score ranging from 0 to 20. The total of the four dimensions has been analyzed. The unit of measure is "score". | From enrollment to the end of treatment on day 14. |
| Number of Treatment-emergent Adverse Events | Safety and tolerability will be evaluated through the incidence of Adverse Event, Serious Adverse Event, Adverse Device Effect, Serious Adverse Device Effect, Anticipated Serious Adverse Device Effect, and Unanticipated Serious Adverse Device Effect assessed by Investigator and reported according to the current legislation for the whole study period. Device Deficiency will be also evaluated. The number of adverse events recorded will be evaluated to measure the safety of the MD. | From enrollment to the end of study on day 30. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients diagnosed with Grade I - II symptomatic haemorrhoids (Goligher classification) | The Haemorrhoid Severity Score (HSS), a physician-reported outcome, will be completed by Investigator at baseline and day 30, at the end of the treatment with the medical device. Grades on a scale from 1 to 5, where lower grades are better with a total of 4 items on the questionnaire (minimum score 4, maximum score 20). The change of the total score of the HSS questionnaire between baseline and the end of the study will be assessed according to the Protocol by means of the Wilcoxon signed-rank test. | Mean | Standard Deviation | Score |
|
| Quality of Life measured by The Short Health Scale for Haemorrhoidal Disease (SHSHD) | The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 30, at the end of the treatment with the medical device. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). The change of the total score of the SHSDH scale between baseline and the end of the study will be assessed according to the Protocol by means of the Wilcoxon signed-rank test. | Mean | Standard Deviation | Score |
|
| Quality of Life measured by The Haemorrhoidal Disease Symptom Score (HDSS) | The Haemorrhoidal Disease Symptom Score (HDSS), a patient-reported outcome questionnaire, will be administered by Investigator to each patient at baseline and at day 30, at the end of the treatment with the medical device. Grades on a scale from 1 to 5, where lower grades are better, with a total of 5 items on the questionnaire (minimum score 5, maximum score 25). The change of the total score of the HDSS questionnaire between baseline and the end of the study will be assessed according to the Protocol by means of the Wilcoxon signed-rank test. | Mean | Standard Deviation | Score |
|
| Title |
|---|
| Description |
|---|
| OG000 | PROCTOeze® PLUS | Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology. |
|
|
|
| Secondary | Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician | HSS is a physician-reported measurement instrument based on PNR-Bleed classification. All four components in this classification system are graded into five grades ranging from 1 to 5. Grade 1 is the normal anal cushions and Grade 5 is the worst grade in a specific characteristic. HSS is the total score obtained by the sum of the numerical grades of all four characteristics of haemorrhoids in the PNR-Bleed classification. The minimum HSS score is 4 and the maximum score can be 20. The HSS score of a normal person without any signs and symptoms of haemorrhoids is 4. Calculation of the HSS helps in the quantification of the haemorrhoidal disease for further reference and is helpful in post-treatment patient follow-up to grade the response to treatment and to assess the effectiveness or failure of any particular treatment regimen for haemorrhoids. The total of the four dimensions has been analyzed. The unit of measure is "score". | Posted | Mean | Standard Deviation | Score | From enrollment to the end of treatment on day 14. |
|
|
|
|
| Secondary | Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient | The Haemorrhoidal Disease Symptom Score (HDSS), a patient-reported outcome questionnaire, will be administered by Investigator to each patient at baseline and at day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 5, where lower grades are better, with a total of 5 items on the questionnaire. The HDSS is a patient-reported measurement instrument. It comprises five items. Symptoms are assessed using the patient-reported frequency of the 5 symptoms, including pain, itching, bleeding, soiling, and prolapse. Patients are instructed to answer based on their experience during the previous period. Each symptom is graded on a 5-point scale (0 = never, 1 = less than once a month, 2 = less than once a week, 3 = 1-6 days per week, 4 = every day or always), giving a total score ranging from 0 to 20. The total of the four dimensions has been analyzed. The unit of measure is "score". | Posted | Mean | Standard Deviation | Score | From enrollment to the end of treatment on day 14. |
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| Secondary | Number of Treatment-emergent Adverse Events | Safety and tolerability will be evaluated through the incidence of Adverse Event, Serious Adverse Event, Adverse Device Effect, Serious Adverse Device Effect, Anticipated Serious Adverse Device Effect, and Unanticipated Serious Adverse Device Effect assessed by Investigator and reported according to the current legislation for the whole study period. Device Deficiency will be also evaluated. The number of adverse events recorded will be evaluated to measure the safety of the MD. | Posted | Number | Adverse events | From enrollment to the end of study on day 30. |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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