Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 5:49 PM
Study NCT ID:
NCT04292808
Status:
WITHDRAWN
Last Update Posted:
2023-05-06
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008733', 'term': 'Methoxyflurane'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Covid caused too many delays', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing patient satisfaction', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Global assessment of medication performance (gmp)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '5512851', 'type': 'BACKGROUND', 'citation': 'Romagnoli A, Busque L, Power DJ. The "analgizer" in a general hospital: a preliminary report. Can Anaesth Soc J. 1970 May;17(3):275-8. doi: 10.1007/BF03004607. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.medsafe.govt.nz/profs/datasheet/p/penthroxinh.pdf', 'label': 'Penthrox Data Sheet - New Zealand (2017)'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (PENTHROX®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections \\[eg. hyaluronic acid (HA) and Sculptra®\\] in an outpatient aesthetic practice. This will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Conscious adult patients: ≥ 18 years of age\n2. Patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. HA, and Sculptra®).\n3. Patient should understand the nature of the study and provide written informed consent\n4. Patient is able to follow all study requirements and procedures and complete required questionnaires\n\nExclusion Criteria:\n\n1. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol\n2. Clinically significant renal impairment\n3. Women of child bearing potential who are pregnant or peri partum, including labour\n4. A history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics\n5. Hypersensitivity to methoxyflurane or other halogenated anesthetics, or to butylated hydroxytoluene\n6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives\n7. Clinically evident or potential hemodynamic instability as per the opinion of the investigator\n8. Clinically evident respiratory impairment as per the opinion of the investigator\n9. Prior treatment with PENTHROX® within 3 months'}, 'identificationModule': {'nctId': 'NCT04292808', 'briefTitle': 'Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler', 'organization': {'class': 'OTHER', 'fullName': 'Verso Surgery Centre'}, 'officialTitle': 'An Open-Label Study to Assess the Efficacy and Safety of Low Dose Methoxyflurane (PENTHROX®) for Pain Control During Outpatient Aesthetic Surgeries and Facial Filler Injections', 'orgStudyIdInfo': {'id': 'PRO00040577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Penthrox', 'description': 'Low Dose Methoxyflurane', 'interventionNames': ['Drug: Methoxyflurane']}], 'interventions': [{'name': 'Methoxyflurane', 'type': 'DRUG', 'otherNames': ['Penthrox'], 'description': 'Methoxyflurane inhaler during out-patient aesthetics surgery or facial dermal fillers.', 'armGroupLabels': ['Penthrox']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6J 0A3', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Verso Surgery Centre', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verso Surgery Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}