Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-29 @ 12:22 AM
Study NCT ID:
NCT01534832
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance of a clear visual field during surgery', 'timeFrame': '3m'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgical smoke', 'laparoscopic surgery', 'impaired vision'], 'conditions': ['Focus: Surgical Smoke During Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.', 'detailedDescription': 'The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, at least 18 years of age\n2. Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease\n3. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.\n\nExclusion Criteria:\n\n1. \\<18 years of age\n2. Pregnant or lactating females\n3. Previous extensive abdominal surgery, which in the opinion of the Investigator presents a \\>5% risk of conversion to an open procedure being required\n4. Current participation in another device or drug study\n5. Unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01534832', 'acronym': 'Innervision', 'briefTitle': 'Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asalus Medical Instruments Limited'}, 'officialTitle': 'Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'AMIL/2011/INV01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smoke clearance', 'description': 'Smoke clearance device active', 'interventionNames': ['Device: Innervision Surgical Smoke Removal System']}], 'interventions': [{'name': 'Innervision Surgical Smoke Removal System', 'type': 'DEVICE', 'description': 'Smoke removal by electrostatic precipitation', 'armGroupLabels': ['Smoke clearance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF64 2XX', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'University Hospital Llandough', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Jared Torkington, MBBS MS FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff and Vale UHB, Wales, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asalus Medical Instruments Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}