Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT01624350
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michelle.v.disalvo@medtronic.com', 'phone': '508.452.4095', 'title': 'Medtronic (Sponsor)', 'organization': 'Medtronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Permacol Collagen Paste', 'otherNumAtRisk': 100, 'otherNumAffected': 29, 'seriousNumAtRisk': 100, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Anal fistula infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Infected fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'purulent discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'hypertrophic scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fistula Healing in Patients at 6 Months Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Permacol Collagen Paste'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.'}, {'type': 'SECONDARY', 'title': 'Fistula Healing in Patients at 3 and 12 Months Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Permacol Collagen Paste - 3 Month Follow up'}, {'id': 'OG001', 'title': 'Permacol Collagen Paste - 12 Month Follow up'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '63.6'}, {'value': '53.5', 'groupId': 'OG001', 'lowerLimit': '43.2', 'upperLimit': '63.6'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '63.6'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '43.2', 'upperLimit': '63.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months and 12 months', 'description': 'Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.'}, {'type': 'SECONDARY', 'title': 'Participant Response to Quality of Life EQ-5D Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline - Pre-operatively'}, {'id': 'OG001', 'title': 'Permacol Collagen Paste - 3 Month Post-op'}, {'id': 'OG002', 'title': 'Permacol Collagen Paste - 6 Month Post-op'}, {'id': 'OG003', 'title': 'Permacol Collagen Paste - 12 Month Post-op'}], 'classes': [{'title': 'I have no problems in walking about', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'I have slight problems in walking about', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'I have moderate problems in walking about', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have severe problems in walking about', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I am unable to walk about', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'I have no problems washing or dressing myself', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'I have slight problems washing or dressing myself', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have moderate problems washing or dressing mysel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have severe problems washing or dressing myself', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'I am unable to wash or dress myself', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'I have no problems doing my usual activities', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'I have slight problems doing my usual activities', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'I have moderate problems doing my usual activities', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have severe problems doing my usual activities', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have no pain or discomfort', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'I have slight pain or discomfort', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'I have moderate pain or discomfort', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'I have severe pain or discomfort', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I have extreme pain or discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'I am not anxious or depressed', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'I am slightly anxious or depressed', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'I am moderately anxious or depressed', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'I am severely anxious or depressed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'I am extremely anxious or depressed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, and 3 months, 6 months and 12 months post op', 'description': 'Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed include participants who completed questionnaire.'}, {'type': 'SECONDARY', 'title': 'Fecal Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Permacol Collagen Paste - 3 Month Post-op'}, {'id': 'OG001', 'title': 'Permacol Collagen Paste - 6 Month Post-op'}, {'id': 'OG002', 'title': 'Permacol Collagen Paste - 12 Month Post-op'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.58', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '3.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months and 12 months', 'description': 'Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Between the First and Last Post-operative Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between the first and last visits', 'description': 'Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants completed a satisfaction questionnaire at least twice.'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline'}, {'id': 'OG001', 'title': 'Permacol Collagen Paste - 1 Month Post-op'}, {'id': 'OG002', 'title': 'Permacol Collagen Paste - 3 Month Post-op'}, {'id': 'OG003', 'title': 'Permacol Collagen Paste - 6 Month Post-op'}, {'id': 'OG004', 'title': 'Permacol Collagen Paste - 12 Month Post-op'}], 'classes': [{'title': 'No Pain (0)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}]}, {'title': 'Mild Pain (1-3)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Moderate Pain (4-6)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Severe Pain (7-10)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months and 12 months', 'description': 'Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants include number of patients who completed questionnaire'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Permacol Collagen Paste'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Permacol Collagen Paste'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '13.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2012-06-15', 'resultsFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-29', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula Healing in Patients at 6 Months Following Surgery', 'timeFrame': '6 months', 'description': 'Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.'}], 'secondaryOutcomes': [{'measure': 'Fistula Healing in Patients at 3 and 12 Months Following Surgery', 'timeFrame': '3 months and 12 months', 'description': 'Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.'}, {'measure': 'Participant Response to Quality of Life EQ-5D Questionnaire', 'timeFrame': 'Baseline, and 3 months, 6 months and 12 months post op', 'description': 'Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.'}, {'measure': 'Fecal Incontinence', 'timeFrame': '3 months, 6 months and 12 months', 'description': 'Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.'}, {'measure': 'Patient Satisfaction Between the First and Last Post-operative Visit', 'timeFrame': 'Between the first and last visits', 'description': 'Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.'}, {'measure': 'Pain', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months and 12 months', 'description': 'Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorectal Fistulas'], 'conditions': ['Anorectal Fistulas']}, 'descriptionModule': {'briefSummary': 'This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.\n\nThe subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.', 'detailedDescription': "The study will enroll 100 subjects at up to 10 centers throughout the European Union. The expected duration of the enrollment period is approximately 9 months. The duration of each subject's participation in the study will be approximately one year. However, at sites where the routine follow-up period is greater than one year, subjects may be followed for up to 36 months at their surgeon's discretion if they agree to it."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects who meet the eligibility criteria that are planned to undergo surgical treatment for anorectal fistulas with Permacol™ Collagen Paste and agree to 12 months of follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female subjects age 18 or older\n2. Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin\n\nKey Exclusion Criteria:\n\n1. History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)\n2. Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas\n3. Indication of an actively infected fistula/abscess (acute sepsis)"}, 'identificationModule': {'nctId': 'NCT01624350', 'briefTitle': 'A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'MASERATI 100 - A Prospective, Multi-center, Post-mArket, Single-arm obsERvATIonal Study to Collect Clinical Outcome Data on the Use of Permacol™ Collagen Paste in the Treatment of Anorectal Fistulas', 'orgStudyIdInfo': {'id': 'COVPERP0200'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Permacol collagen paste', 'type': 'DEVICE', 'description': 'Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Casa di Cura PIO X', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Pordenone', 'country': 'Italy', 'facility': 'AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital & Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Whipps Cross University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Pasquale Giordano, MD, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Whipps Cross University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}