Haemorrhoidal DiseaseNCT06944951
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS
A study testing Hydrophilic emulsion for the relief of haemorroidal symptoms in people with Haemorrhoidal Disease, run by Biokosmes Srl at 1 site in Romania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoidal Disease
- What is being tested?
- Hydrophilic emulsion for the relief of haemorroidal symptoms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 5 Nov 2024to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years old.
- Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline.
- Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation.
- Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents.
- Patients able to communicate adequately with the Investigator and understand the tral questionnaire.
- Patients able to understand and who can provide valid informed consent to the trial.
Who cannot join
- Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease).
- Frequent hemorraidal bleeding
- Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
- Patients with known sensitivity to the tested medical device or its components.
- Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device PROCTOeze® PLUS in the Relief of Haemorrhoidal Disease and Anal Irritation Symptoms
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.
Read the detailed description
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.
- Conditions
- Haemorrhoidal Disease
- Being tested
- Hydrophilic emulsion for the relief of haemorroidal symptoms
- Keywords
- haemorroidal disease, haemorroidal crisis, internal haemorroids, external haemorroids, anal irritation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic emulsion for the relief of haemorroidal symptomsDevice
Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.
| Study group | Role | What they receive |
|---|---|---|
| PROCTOeze® PLUS | Experimental | Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology. Receives: Device: Hydrophilic emulsion for the relief of haemorroidal symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment on day 14.
Secondary outcomes (3)
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".
Measured: 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".
Measured: 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.
Measured: From enrollment to the end of study on day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start5 Nov 2024
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haemorrhoidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biokosmes Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucia Cristina Sisu, Dr., Principal investigator, CMI Dr Sisu Lucia Cristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944951
- Sponsor's protocol ID
- OpBio/0123/MD
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2025
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device PROCTOeze® PLUS in the Relief of Haemorrhoidal Disease and Anal Irritation Symptoms
- ClinicalTrials.gov ID
- NCT06944951
- Acronym / sponsor ID
- OpBio/0123/MD
- Conditions
- Haemorrhoidal Disease
- Keywords
- haemorroidal disease, haemorroidal crisis, internal haemorroids, external haemorroids, anal irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biokosmes SrlIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROCTOeze® PLUS | Experimental | Device: Hydrophilic emulsion for the relief of haemorroidal symptomsAdministration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥ 18 years old.
- Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline.
- Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation.
- Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents.
- Patients able to communicate adequately with the Investigator and understand the tral questionnaire.
Key exclusion criteria (6 listed)
- Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease).
- Frequent hemorraidal bleeding
- Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
- Patients with known sensitivity to the tested medical device or its components.
- Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrophilic emulsion for the relief of haemorroidal symptomsAdministration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation. | Device | PROCTOeze® PLUS |
Primary outcome
Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD)
Time frame: From enrollment to the end of treatment on day 14.
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.
3 secondary outcomes
Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician
Time frame: From enrollment to the end of treatment on day 14.
Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient
Time frame: From enrollment to the end of treatment on day 14.
Number of Treatment-emergent Adverse Events
Time frame: From enrollment to the end of study on day 30.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Haemorrhoidal Disease
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Recruiting
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Haemorrhoids, Internal Haemorrhoids
RecruitingObservational study
Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty
Haemorrhoid, Haemorrhoidal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Cristina Sisu, Dr. principal investigator
CMI Dr Sisu Lucia Cristina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrophilic emulsion for the relief of haemorroidal symptoms in people with Haemorrhoidal Disease, run by Biokosmes Srl at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) (time frame: From enrollment to the end of treatment on day 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.