Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-02 @ 8:50 AM
Study NCT ID:
NCT07245628
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-10', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)', 'description': 'Measuring the mean difference in Visual Analog Scale for Anxiety (VAS-A) during the vasectomy procedure and the Situational Pain Catastrophizing Scale (S-PCS) immediately after the vasectomy procedure, comparing those receiving and not receiving self-administered low dose nitrous oxide.\n\nIntra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)\n\nIntra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)\n\nPost-Procedure (10 Minutes After Procedure Completion, to Allow for Nitrous Oxide to be Metabolized)\n\n1. Situational Pain Catastrophizing Scale (S-PCS) (Zero is equivalent to not at all and 4 indicates all the time)\n2. Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)'}], 'secondaryOutcomes': [{'measure': 'Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)', 'description': 'Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)\n\nIntra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)'}, {'measure': 'Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)', 'description': 'Pre-Procedure (Day of Procedure, Immediately Prior)\n\n1. Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)\n2. State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much)\n\nPost-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)\n\n1. Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)\n2. State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much)'}, {'measure': 'Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Study Enrollment - 30 Days After Vasectomy', 'description': 'Measured using the The Common Terminology Criteria for Adverse Events (CTCAE) grading scale (v5.0).\n\nCTCAE v5.0 (1 is equivalent to mild and 5 indicates death related to AE)'}, {'measure': 'Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Post-Procedure, Day of Vasectomy', 'description': 'Post-Procedure, Day of Vasectomy Ease of Procedure (1 is equivalent to the urologist determining the procedure went worse than expected and 3 indicates the urologist determines the procedure went better than expected)'}, {'measure': 'Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Post-Procedure, Day of Vasectomy', 'description': "Patient Tolerance (1 is equivalent to the urologist determining the patient's tolerance for the procedure was worse than expected and 3 indicates the urologist determines the patient's tolerance for the procedure was better than expected)"}, {'measure': 'Mean Difference in Duration of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide', 'timeFrame': 'Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vasectomy', 'Nitrous Oxide', "Men's Health"], 'conditions': ['Vasectomy']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting.\n\nThis trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy.\n\nThe main questions it aims to answer are:\n\n* Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy.\n* To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure.\n\nParticipants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 85 at the time of screening\n* Desiring vasectomy for family planning purposes\n* Able to understand and complete patient questionnaires\n* Willing and able to provide written consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with unilateral absence of the vas deferens\n* Patients who are deemed by study surgeons to have anatomy no amendable for office procedure\n* Patients who decline office vasectomy and request monitored anesthesia care\n* Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure\n* Patients with contraindications to nitrous oxide including:\n* Inner ear, bariatric, or eye surgery within the past 2 weeks\n* Current emphysematous blebs\n* Severe B-12 deficiency\n* History of bleomycin chemotherapy within the last year\n* Class III or higher heart failure'}, 'identificationModule': {'nctId': 'NCT07245628', 'briefTitle': 'A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy', 'orgStudyIdInfo': {'id': '2025P000258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide', 'description': 'Self-Administered Nitrous Oxide', 'interventionNames': ['Drug: Nitrous Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Oxygen)', 'description': 'Self-Administered Placebo (Oxygen)', 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'Self-Administered Nitrous Oxide', 'armGroupLabels': ['Nitrous Oxide']}, {'name': 'Oxygen', 'type': 'DRUG', 'description': 'Self-Administered Oxygen', 'armGroupLabels': ['Placebo (Oxygen)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra J Berger Eberhardt, MD', 'role': 'CONTACT', 'email': 'ajberger@bwh.harvard.edu', 'phone': '617-983-4521'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alexandra J Berger Eberheardt, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandra J. Berger Eberhardt, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Associate Surgeon, Department of Urology, Brigham and Women's Hospital; Assistant Professor, Harvard Medical School", 'investigatorFullName': 'Alexandra J. Berger Eberhardt, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}