Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06243718
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis: Patient Experiences and Reported Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012133', 'term': 'Respiratory Paralysis'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-Structured Interviews.', 'timeFrame': 'Participants are interviewed one week before and 12 months after the surgery.', 'description': 'The interviews will serve a dual purpose: first, to delve into the daily experiences of individuals living with diaphragmatic paralysis, aiming to uncover the practical and emotional realities they face; and second, to explore the experiences and perceived outcomes of phrenic nerve surgery as a treatment for diaphragmatic paralysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Grounded Theory', 'Diaphragmatic Paralysis', 'Diaphragm', 'Respiratory System', 'Pain'], 'conditions': ['Diaphragmatic Paralysis', 'Pain, Chest', 'Breath Shortness']}, 'referencesModule': {'references': [{'pmid': '36031309', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Ferro N, Paulin E. Phrenic nerve paralysis and phrenic nerve reconstruction surgery. Handb Clin Neurol. 2022;189:271-292. doi: 10.1016/B978-0-323-91532-8.00003-3.'}, {'pmid': '34397519', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Chang EI, Bauer T, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Phrenic Nerve Reconstruction for Effective Surgical Treatment of Diaphragmatic Paralysis. Ann Plast Surg. 2021 Sep 1;87(3):310-315. doi: 10.1097/SAP.0000000000002896.'}, {'pmid': '25834691', 'type': 'BACKGROUND', 'citation': 'Cece J, Aboharb F, Rezzadeh KS, Brown D, Jarrahy R, Kaufman MR. Klippel-feil syndrome and unilateral diaphragmatic paralysis. Eplasty. 2015 Feb 10;15:ic10. eCollection 2015. No abstract available.'}, {'pmid': '33432336', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Bauer T, Onders RP, Brown DP, Chang EI, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Treatment for bilateral diaphragmatic dysfunction using phrenic nerve reconstruction and diaphragm pacemakers. Interact Cardiovasc Thorac Surg. 2021 May 10;32(5):753-760. doi: 10.1093/icvts/ivaa324.'}, {'pmid': '33054689', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Bauer T, Campbell S, Rossi K, Elkwood A, Jarrahy R. Prospective analysis of a surgical algorithm to achieve ventilator weaning in cervical tetraplegia. J Spinal Cord Med. 2022 Jul;45(4):531-535. doi: 10.1080/10790268.2020.1829417. Epub 2020 Oct 15.'}, {'pmid': '24266954', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Colicchio AR, CeCe J, Jarrahy R, Willekes LJ, Rose MI, Brown D. Functional restoration of diaphragmatic paralysis: an evaluation of phrenic nerve reconstruction. Ann Thorac Surg. 2014 Jan;97(1):260-6. doi: 10.1016/j.athoracsur.2013.09.052. Epub 2013 Nov 19.'}, {'pmid': '27665114', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Brown D, Cece J, Martins C, Bauer T, Weissler J, Rezzadeh K, Jarrahy R. Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):63-69. doi: 10.1055/s-0036-1588018. Epub 2016 Sep 25.'}, {'pmid': '28709166', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Brown D, Cece J, Martins C, Bauer T, Weissler J, Rezzadeh K, Jarrahy R. Erratum to: Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):e1-e2. doi: 10.1055/s-0037-1604271. Epub 2017 Jul 14.'}, {'pmid': '22366245', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Willekes LJ, Elkwood AI, Rose MI, Patel TR, Ashinoff RL, Colicchio AR. Diaphragm paralysis caused by transverse cervical artery compression of the phrenic nerve: the Red Cross syndrome. Clin Neurol Neurosurg. 2012 Jun;114(5):502-5. doi: 10.1016/j.clineuro.2012.01.048. Epub 2012 Feb 24.'}, {'pmid': '23838708', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Fields R, Brown D. Surgical treatment of permanent diaphragm paralysis after interscalene nerve block for shoulder surgery. Anesthesiology. 2013 Aug;119(2):484-7. doi: 10.1097/ALN.0b013e31829c2f22. No abstract available.'}, {'pmid': '21349932', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Saad A, Caccavale R, Bocage JP, Cole J, Soriano A, Fein E. Reinnervation of the paralyzed diaphragm: application of nerve surgery techniques following unilateral phrenic nerve injury. Chest. 2011 Jul;140(1):191-197. doi: 10.1378/chest.10-2765. Epub 2011 Feb 24.'}, {'pmid': '25868155', 'type': 'BACKGROUND', 'citation': 'Kaufman MR, Elkwood AI, Aboharb F, Cece J, Brown D, Rezzadeh K, Jarrahy R. Diaphragmatic reinnervation in ventilator-dependent patients with cervical spinal cord injury and concomitant phrenic nerve lesions using simultaneous nerve transfers and implantable neurostimulators. J Reconstr Microsurg. 2015 Jun;31(5):391-5. doi: 10.1055/s-0035-1549159. Epub 2015 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'This study utilizes a grounded theory methodology to explore patient experiences of phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a confirmed diagnosis of Diaphragmatic Paralysis.\n* Individuals who are scheduled to undergo phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.\n\nExclusion Criteria:\n\n\\- Individuals who do not comprehend the English language.'}, 'identificationModule': {'nctId': 'NCT06243718', 'briefTitle': 'Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis: Patient Experiences and Reported Outcomes.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Advanced Reconstructive Surgery Alliance'}, 'officialTitle': 'A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes.', 'orgStudyIdInfo': {'id': 'GT-Phase-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '07701', 'city': 'Red Bank', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeannine Sico, RN', 'role': 'CONTACT', 'email': 'jsico@arsahealth.com', 'phone': '732-741-0970', 'phoneExt': '1175'}, {'name': 'Jennifer Tarquinio', 'role': 'CONTACT', 'email': 'jtarquinio@sycamoremm.com', 'phone': '888-915-7617'}, {'name': 'Matthew Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advanced Reconstructive Surgery Alliance', 'geoPoint': {'lat': 40.34705, 'lon': -74.06431}}, {'zip': '07702', 'city': 'Shrewsbury', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeannine Sico, RN', 'role': 'CONTACT', 'email': 'jsico@arsahealth.com', 'phone': '732-741-0970', 'phoneExt': '1175'}, {'name': 'Jennifer Tarquinio', 'role': 'CONTACT', 'email': 'jtarquinio@sycamoremm.com', 'phone': '888-915-7617'}, {'name': 'Matthew Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute for Advanced Reconstruction', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}], 'centralContacts': [{'name': 'Jeannine Sico, RN.', 'role': 'CONTACT', 'email': 'jsico@arsahealth.com', 'phone': '732-741-0970', 'phoneExt': '1175'}, {'name': 'Jennifer Tarquinio, MSc.', 'role': 'CONTACT', 'email': 'jtarquinio@sycamoremm.com', 'phone': '888-915-7617'}], 'overallOfficials': [{'name': 'Matthew Kaufman, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Reconstructive Surgery Alliance'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Reconstructive Surgery Alliance', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Plastic and Reconstructive Surgeon', 'investigatorFullName': 'Matthew Kaufman, MD', 'investigatorAffiliation': 'Advanced Reconstructive Surgery Alliance'}}}}