Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 11:30 PM
Study NCT ID:
NCT06923150
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LARS score difference', 'timeFrame': '3-month follow-up', 'description': 'The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.'}], 'secondaryOutcomes': [{'measure': 'efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks', 'timeFrame': '6-week follow-up', 'description': 'LARS difference score between inclusion and 6-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals'}, {'measure': 'QoL with the EORTC QLQ-C30 EORTC QLQ-CR29', 'timeFrame': '3-month follow- up', 'description': 'EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 3-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.\n\nAlso, statistical tests of superiority will be performed comparing EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences between inclusion and 3-month follow-up between interventional arm and control arm'}, {'measure': 'change (reduction) of symptoms and consequences', 'timeFrame': '6 weeks and 12 weeks', 'description': 'To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6 and 12 weeks The number and the proportion of patients with each item of the LARS international consensus definition at 6 and 12 weeks will be calculated.\n\nAlso, the proportion of patients who are considered as having no LARS at 6 and 12 weeks will be calculated with a confidence interval'}, {'measure': 'patient satisfaction', 'timeFrame': '6 weeks and 12 weeks', 'description': 'to assess the patient satisfaction at 6 and 12 weeks, The proportion of patients satisfied by the treatment evaluated with the 5-point Likert Scale at 6 and 12 weeks will be calculated with a confidence interval.'}, {'measure': 'compliance of the patient to the treatmen', 'timeFrame': '6 weeks and 12 weeks', 'description': 'to assess the compliance of the patient to the treatment at 6 and 12 weeks Compliance with the treatment during the 6 and 12 weeks of study with the number of days of MiniGo use per week will be calculated using descriptive statistics and confidence intervals'}, {'measure': 'incontinence anal score', 'timeFrame': '12 weeks', 'description': 'To access the incontinence anal score at 12 weeks Wexner difference score between inclusion and 12-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.\n\nAlso, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-week follow-up between interventional arm and control arm.'}, {'measure': 'reduction of defecations per day and night', 'timeFrame': '6 weeks and 12 weeks', 'description': 'To assess the reduction of defecations per day and night The mean number of defecations per day and per night during the week before the randomisation and the week before the follow-up visit at 6 and 12 weeks will be calculated.'}, {'measure': 'time spent on bowel management (in the toilets room)', 'timeFrame': '12 weeks', 'description': 'To assess the time spent on bowel management (in the toilets room) Mean times spent in the toilets room per day the week before the randomisation and the week before the follow-up visit at 12 weeks will be calculated using descriptive statistics.'}, {'measure': 'patient health organization and resources needed', 'timeFrame': '12 weeks', 'description': 'To evaluate the patient health organization and resources needed at 12 weeks Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics.'}, {'measure': 'improving the LARS score', 'timeFrame': '6, 9 and 12 months', 'description': 'to assess the efficacy on clinical symptom of Transanal Irrigation by MiniGo in improving the LARS score at 6, 9 and 12 months LARS difference score between inclusion and 6, 9 and 12-month follow-ups will be calculated using descriptive statistics and confidence intervals.'}, {'measure': 'number of patients showing a change (reduction) of symptoms and consequences', 'timeFrame': '6, 9 and 12 months', 'description': 'To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6, 9 and 12 months The number and the proportion of patients with each item of the LARS international consensus definition at 6, 9 and 12 months will be calculated.\n\nAlso, the proportion of patients who are considered as having no LARS at 6, 9 and 12 months will be calculated with a confidence interval.'}, {'measure': 'Preference of the patient and reason for it', 'timeFrame': '12 month follow-up', 'description': 'To assess the preference of the patient and reason for it Proportion of patients who stay on TAI treatment for TAI arm and proportion of patients from SOC arm whose tries and stay on TAI will be calculated using confidence intervals. Description of reasons will be also presented.'}, {'measure': 'QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month', 'timeFrame': '12-month follow-up', 'description': 'to assess the QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 12-month follow-ups will be calculated for each randomised arm using descriptive statistics and confidence intervals.'}, {'measure': 'incontinence anal score at 12 months', 'timeFrame': '12-month follow-up', 'description': 'Wexner difference score between inclusion and 12-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.\n\nAlso, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-month follow-up between interventional arm and control arm'}, {'measure': 'patient health organization and resources needed at 6, 9 and 12 months', 'timeFrame': '6, 9 and 12 months', 'description': 'Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LARS', 'Transanal Irrigation', 'Minigo', 'rectal cancer'], 'conditions': ['Gastroenterology', 'LARS - Low Anterior Resection Syndrome', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'minor and major LARS patients LARS score \\>= 25', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult aged from 18 years\n2. Patients electively treated for rectal cancer with a low anterior resection\n3. Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable\n4. LARS score \\>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)\n5. Adult for whom previous conservative treatments were started for at least a month\n6. Mental and physical capability of the patient to handle the MiniGo by himself.\n7. Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice\n8. Patient affiliated to the health social security system\n\nExclusion Criteria:\n\n1. Contra-indication to use TAI\n2. Former use of TAI (post colo-rectal surgery)\n3. Clinically relevant stenosis\n4. Current metastatic disease or local recurrence\n5. Ongoing chemotherapy\n6. Postoperative radiotherapy for rectal cancer\n7. History of diarrhoeal disease\n8. Inflammatory bowel disease\n9. Dementia\n10. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.\n11. Patient with cancer recurrence\n12. Patient with a life expectancy \\< 1 year\n13. Participating to another clinical trial for the treatment of LARS symptom\n14. Ongoing pelvic floor rehabilitation/biofeedback\n15. Pregnancy or intention to become pregnant during the trial period\n16. Inability and unwillingness to give informed consent"}, 'identificationModule': {'nctId': 'NCT06923150', 'acronym': 'MINIGO', 'briefTitle': 'A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qufora A/S'}, 'officialTitle': 'A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients', 'orgStudyIdInfo': {'id': '2023-A02656-39'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAI + SOC', 'description': 'Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments'}, {'label': 'SOC', 'description': 'Standard of Care (SOC) conservative treatments:\n\ndietary management, counselling, medication: anti-diarrheic or constipation treatment according to the prescription following usual practice, and food supplement excluding: suppository, ano-rectal stimulation, physiotherapy small enemas, etc…'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles SABBAGH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Zaher LAKKIS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin DENOST', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Tivoli-Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc FAUCHERON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '13005', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane MEGE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie DUCHALAIS DASSONNEVILLE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de NANTES, Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '33604', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin FERNANDEZ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eddy COTTE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '76 031', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie BRIDOUX', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Charles Nicolle - Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Rogini Balachandran', 'role': 'CONTACT', 'email': 'rob@qufora.com', 'phone': '+ 45 42 40 06 20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qufora A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EVAMED', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}