Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 5:57 AM
Study NCT ID:
NCT05243966
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myriad™ Augmented Soft Tissue Reconstruction Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012883', 'term': 'Skin Ulcer'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with treatment emergent adverse events during the study', 'timeFrame': '3 years', 'description': 'Nature, frequency, and severity of adverse events'}], 'secondaryOutcomes': [{'measure': 'Time (weeks) to complete healing', 'timeFrame': 'Up to 52 weeks', 'description': 'When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded'}, {'measure': 'Percentage of surgical complications', 'timeFrame': 'Up to 3 months', 'description': 'Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures'}, {'measure': 'Time (weeks) to 100% granulation', 'timeFrame': 'Up to 3 months', 'description': 'Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded'}, {'measure': 'Percentage of split thickness skin graft take at 1 week post Matrix™ application', 'timeFrame': '1 week post application', 'description': 'Where applicable, when Myriad™ is used for dermal regeneration and a split thickness skin graft is used the percentage of graft take at 1 week will be recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Soft tissue reconstruction', 'Limb salvage', 'Extracellular matrix', 'Soft tissue reinforcement', 'Wound reconstruction', 'Regenerative medicine'], 'conditions': ['Abdominal Wound Dehiscence', 'Necrotizing Soft Tissue Infection', 'Lower Extremity Wound', 'Pilonidal Sinus', 'Anal Fistula', 'Hidradenitis Suppurativa', 'Pressure Injury']}, 'descriptionModule': {'briefSummary': 'This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.', 'detailedDescription': 'This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.\n\nThe study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.\n\nParticipants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:\n\n* Abdominal dehiscence\n* Necrotizing soft tissue infection (NSTI)\n* Lower extremity complex non-healing wounds (limb salvage)\n* Pilonidal sinus disease\n* Anal fistula\n* Hidradenitis suppurativa reconstruction\n* Pressure injury reconstruction\n\nOther procedure types may be included at the discretion of the Investigator/Research Team.\n\nParticipants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriad™ devices as part of Standard of Care (SoC).\n\nThe pre-operative care and preparation of the surgical site (prior to the application of Myriad™ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ devices. The participants post-operative care is at the discretion of the attending physician.\n\nEarly and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.\n\nThrough the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is being carried out at approximately 10 sites in the U.S. Across all sites, about 300 individuals will participate in the study where the Investigator is planning to utilize Myriad™ as a part of their surgical procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan\n* Male or female patients aged 18 years or above\n* Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure\n* Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule\n\nExclusion Criteria:\n\n* Patients with known sensitivity to ovine (sheep) derived material\n* Patients with full thickness ('third degree') burns\n* Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)\n* Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study\n* Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment\n* Pregnant or lactating women\n* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study"}, 'identificationModule': {'nctId': 'NCT05243966', 'acronym': 'MASTRR', 'briefTitle': 'Myriad™ Augmented Soft Tissue Reconstruction Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aroa Biosurgery Limited'}, 'officialTitle': 'Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures', 'orgStudyIdInfo': {'id': 'CIP.SUR.001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myriad™', 'description': 'Ovine forestomach matrix sheet graft and morselized extracellular matrix', 'interventionNames': ['Device: Myriad Matrix™ and Myriad Morcells™']}], 'interventions': [{'name': 'Myriad Matrix™ and Myriad Morcells™', 'type': 'DEVICE', 'description': 'Ovine forestomach matrix sheet graft and morselized extracellular matrix', 'armGroupLabels': ['Myriad™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yosef Nasseri, MD, FACS, FACRS', 'role': 'CONTACT', 'phone': '310-861-7493'}, {'name': 'Yosef Nasseri, MD, FACS, FACRS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moshe Barnajian, MD, FACRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Surgery Group LA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33919', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Associates in Medicine & Surgery', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kymberly Palmer', 'role': 'CONTACT', 'email': 'Kymberly.palmer@ascension.org', 'phone': '813-843-1398'}, {'name': 'Kyle J. Leneweaver, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asencion Sacred Heart', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Murdoch', 'role': 'CONTACT', 'email': 'Emily.murdoch@nghs.com', 'phone': '(770)-219-3438'}, {'name': 'William M Vassy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael T Cormican, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Northeast Georgia Medical Center, Inc.', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Smith, MD, PhD', 'role': 'CONTACT', 'email': 'asmi60@lsuhsc.edu', 'phone': '504-903-9009'}, {'name': 'Frank Lau, MD', 'role': 'CONTACT', 'email': 'flau@lsuhsc.edu', 'phone': '504-412-1240'}, {'name': 'Alison Smith, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Frank Lau, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Ochsner Baptist Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '443-220-1438'}, {'name': 'Joshua Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Nuvance Health Vassar Brothers Medical Center', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '27401-1004', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Moses H Cone Memorial Hospital Operating Corporation', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Tower Health Reading Hospital', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}], 'centralContacts': [{'name': 'Barnaby May, PhD', 'role': 'CONTACT', 'email': 'barnaby.may@aroa.com', 'phone': '+64 21 056 9995'}, {'name': 'Brandon Bosque, DMP,CWSP', 'role': 'CONTACT', 'email': 'Brandon.Bosque@aroa.com'}], 'overallOfficials': [{'name': 'Tracee Short, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Short Consulting Group, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aroa Biosurgery Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}