Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT04015193
Status:
UNKNOWN
Last Update Posted:
2019-07-10
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of SPTS in Patients With Raynaud's Phenomenon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}], 'ancestors': [{'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005791', 'term': 'Patient Care'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean finger ischemia time', 'timeFrame': '5 year', 'description': 'Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 5 years of follow-up, in minutes'}], 'secondaryOutcomes': [{'measure': 'Mean finger ischemia time', 'timeFrame': '2 year', 'description': 'Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 2 years of follow-up, in minutes'}, {'measure': 'Raynaud Condition Score', 'timeFrame': '1,2,3,4,5 years', 'description': 'Mean Raynaud condition score (0-100) over a period 14 days'}, {'measure': 'Number of attacks', 'timeFrame': '1,2,3,4,5 years', 'description': 'Mean number of RP attacks per day over a period of 14 days'}, {'measure': 'Duration of attacks', 'timeFrame': '1,2,3,4,5 years', 'description': 'Mean duration of RP attacks per day over a period of 14 days in minutes'}, {'measure': 'SF-36', 'timeFrame': '1,2,3,4,5 years', 'description': 'Health-related quality of life short form (SF)-36 score of 100-0'}, {'measure': 'HAQ', 'timeFrame': '1,2,3,4,5 years', 'description': '(Dutch) health assessment questionnaire (HAQ) score of 0-3'}, {'measure': 'Capillary density', 'timeFrame': '2 and 5 years', 'description': 'Mean number of capillaries per finger of 8 fingers per 3mm'}, {'measure': 'Number of dilated capillaries', 'timeFrame': '2 and 5 year', 'description': 'Mean number of dilated capillaries per finger (apex width \\>20µm, \\<50µm) of 8 fingers per 3mm'}, {'measure': 'Number of giant capillaries', 'timeFrame': '2 and 5 year', 'description': 'Mean number of giant capillaries per finger (apex width \\>50µm) of 8 fingers per 3mm'}, {'measure': 'Capillaroscopic pattern', 'timeFrame': '2 and 5 year', 'description': 'Pattern of nailfold capillaries (normal, non-specific, early, active or late)'}, {'measure': 'Pulse wave velocity brachial-radial', 'timeFrame': '2 and 5 years', 'description': 'Pulse wave velocity in m/s of brachial-radial trajectory'}, {'measure': 'Systolic blood pressure', 'timeFrame': '2 and 5 years', 'description': 'Brachial systolic blood pressure in mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '2 and 5 years', 'description': 'Brachial diastolic blood pressure in mmHg'}, {'measure': 'Mean finger blood pressure', 'timeFrame': '2 and 5 years', 'description': 'Mean finger blood pressure in mmHg of eight fingers'}, {'measure': 'Pulse wave velocity brachial-ulnar', 'timeFrame': '2 and 5 years', 'description': 'Pulse wave velocity in m/s of brachial-ulnar trajectory'}, {'measure': 'Digital ulcers', 'timeFrame': '1,2,3,4,5 years', 'description': 'Incidence of digital ulcers (yes/no)'}, {'measure': 'Compensatory sweating', 'timeFrame': '1,2,3,4,5 years', 'description': 'Compensatory sweating (yes/no)'}, {'measure': 'Wound infection or other adverse events', 'timeFrame': '2 weeks, 1,2,3,4,5 years', 'description': 'Occurrence of wound infection or other adverse events potentially related to SPTS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Raynaud Phenomenon']}, 'descriptionModule': {'briefSummary': "Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established.\n\nMain research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed.\n\nDesign (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Raynaud's phenomenon", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Raynaud's phenomenon of the hands\n* Scheduled SPTS as treatment for RP\n* Age ≥ 16 years\n\nExclusion Criteria:\n\n• SPTS for other indications than RP"}, 'identificationModule': {'nctId': 'NCT04015193', 'briefTitle': "Follow-up of SPTS in Patients With Raynaud's Phenomenon", 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': "Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon", 'orgStudyIdInfo': {'id': '201900110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full responders', 'description': "Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment.", 'interventionNames': ['Procedure: Single-port thoracoscopic sympathicotomy (patient care)']}, {'label': 'Partial responders', 'description': 'Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.', 'interventionNames': ['Procedure: Single-port thoracoscopic sympathicotomy (patient care)']}, {'label': 'Non-responders', 'description': 'Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery.', 'interventionNames': ['Procedure: Single-port thoracoscopic sympathicotomy (patient care)']}], 'interventions': [{'name': 'Single-port thoracoscopic sympathicotomy (patient care)', 'type': 'PROCEDURE', 'description': 'Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure', 'armGroupLabels': ['Full responders', 'Non-responders', 'Partial responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Douwe J Mulder, MD, PhD', 'role': 'CONTACT', 'email': 'd.j.mulder@umcg.nl', 'phone': '+31-50-3612350'}, {'name': 'Douwe J. Mulder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anniek M. van Roon', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michiel Kuijpers, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Douwe J Mulder, MD, PhD', 'role': 'CONTACT', 'email': 'd.j.mulder@umcg.nl', 'phone': '+31503612943'}], 'overallOfficials': [{'name': 'Douwe J Mulder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Groninge, University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular internist, Principal investigator', 'investigatorFullName': 'dr. DJ Mulder', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}