Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 6:29 AM
Study NCT ID:
NCT06944951
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-18', 'releaseDate': '2025-08-01'}, {'resetDate': '2025-09-16', 'releaseDate': '2025-08-28'}], 'estimatedResultsFirstSubmitDate': '2025-08-01'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of performance by the improvement in the quality of life', 'timeFrame': 'From enrollment to the end of treatment on day 14.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Assessment of performance through Haemorrhoid Severity Score (HSS) reported by physician', 'timeFrame': 'From enrollment to the end of treatment on day 14.', 'description': 'The Haemorrhoid Severity Score (HSS), a physician-reported outcome, will be completed by Investigator at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 5, where lower grades are better.'}, {'measure': 'Assessment of performance through Haemorrhoidal Disease Symptom Score (HDSS) reported by patient', 'timeFrame': 'From enrollment to the end of treatment on day 14.', 'description': '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.'}, {'measure': 'Medical device safety evaluation through incidence of treatment-emergent adverse events', 'timeFrame': 'From enrollment to the end of study on day 30.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haemorroidal disease', 'haemorroidal crisis', 'internal haemorroids', 'external haemorroids', 'anal irritation'], 'conditions': ['Haemorrhoidal Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years old.\n* 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.\n* Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation.\n* 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.\n* Patients able to communicate adequately with the Investigator and understand the tral questionnaire.\n* Patients able to understand and who can provide valid informed consent to the trial.\n\nExclusion Criteria:\n\n* Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease).\n* Frequent hemorraidal bleeding\n* Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.\n* Patients with known sensitivity to the tested medical device or its components.\n* 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.\n* Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.'}, 'identificationModule': {'nctId': 'NCT06944951', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biokosmes Srl'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OpBio/0123/MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROCTOeze® PLUS', 'description': 'Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology.', 'interventionNames': ['Device: Hydrophilic emulsion for the relief of haemorroidal symptoms']}], 'interventions': [{'name': 'Hydrophilic emulsion for the relief of haemorroidal symptoms', 'type': 'DEVICE', 'description': 'Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.', 'armGroupLabels': ['PROCTOeze® PLUS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'C.M.I. Sisu Lucia Cristina', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biokosmes Srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-01', 'type': 'RELEASE'}, {'date': '2025-08-18', 'type': 'RESET'}, {'date': '2025-08-28', 'type': 'RELEASE'}, {'date': '2025-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Biokosmes Srl'}}}}