Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-06 @ 4:57 PM
Study NCT ID:
NCT03167294
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Device Performance Endpoint', 'timeFrame': '6 months', 'description': 'The primary device performance endpoint is completion of the intended surgical procedure.'}, {'measure': 'Primary Safety Endpoint of the study is the perioperative complication rate.', 'timeFrame': '6 months', 'description': 'The primary safety endpoint of the study is the perioperative complication rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aquablation', 'AQUABEAM', 'BPH', 'LUTS'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* 50 - 80 years\n* Moderate to severe BPH\n* Subjects who have failed standard medical therapy\n\nExclusion Criteria:\n\n* Size and width of prostate\n* Medical condition or co-morbidities where BPH intervention would be contraindicated'}, 'identificationModule': {'nctId': 'NCT03167294', 'acronym': 'ABS', 'briefTitle': 'AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'PROCEPT BioRobotics'}, 'officialTitle': 'PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)', 'orgStudyIdInfo': {'id': 'TP0032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH', 'interventionNames': ['Device: AquaBeam System']}], 'interventions': [{'name': 'AquaBeam System', 'type': 'DEVICE', 'description': 'Aquablation', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '387001', 'city': 'Nadiād', 'state': 'Gujarat', 'country': 'India', 'facility': 'Muljibhai Patel Urological Hospital', 'geoPoint': {'lat': 22.69385, 'lon': 72.86157}}], 'overallOfficials': [{'name': 'Ravindra Sabnis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chairman, department of Urology Muljibhai Patel Urological Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROCEPT BioRobotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}