Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT00721461
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2008-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2008-07-22', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the tolerability of the MedPulser DDS device.', 'timeFrame': 'Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.'}]}, 'conditionsModule': {'keywords': ['Assess', 'Tolerability', 'MedPulser DDS device'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between the ages of 18 and 35\n* Woman who are able to become pregnant must use an acceptable form of birth control\n\nExclusion Criteria:\n\n* You are breast feeding\n* You have taken any type of pain reliever within 12 hours of electrostimulation\n* You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study\n* You have muscle atrophy, weakness or neuromuscular disorder'}, 'identificationModule': {'nctId': 'NCT00721461', 'briefTitle': 'A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age', 'orgStudyIdInfo': {'id': 'V930-001'}, 'secondaryIdInfos': [{'id': '2008_537'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'V930', 'interventionNames': ['Biological: V930']}], 'interventions': [{'name': 'V930', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Inovio Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}