Adverse Events Clinical Trial
Official title:
An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
NCT number | NCT05359666 |
Other study ID # | CLP-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 31, 2020 |
Est. completion date | November 29, 2021 |
Verified date | July 2023 |
Source | Irrimax Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of CLP-01 was to complete the safety endpoint of the closed trial and ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for and accurately identified, verified, and independently adjudicated. CLP-01 does not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01. CLP-01 did not enroll new subjects and relied solely on data collected in the subject source and medical records in IRR-CT-901-2013-01. CLP-01 was conducted between March 2020 and November 2021.
Status | Completed |
Enrollment | 592 |
Est. completion date | November 29, 2021 |
Est. primary completion date | November 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Previously consented subjects from the closed study - Subjects randomized to use Irrisept or SoC in the closed study - Subjects who had a procedure in the hospital - Subjects who used irrigation during the hospital procedure - Subjects who had data that could be monitored and verified Exclusion Criteria: -Subjects who did not meet all inclusion criteria The total number of subjects in this population - the mITT population - was 592. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland | Baltimore | Maryland |
United States | University of Cincinnati Division of Trauma/Critical Care Department of Surgery | Cincinnati | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | University of Texas Southwestern (UTSW) Medical Center | Dallas | Texas |
United States | Denver Health Medical Center | Denver | Colorado |
United States | University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research | Houston | Texas |
United States | University of Iowa Department of Surgery - 1504 JCP | Iowa City | Iowa |
United States | University of Kentucky Department of Surgery | Lexington | Kentucky |
United States | Los Angeles County & USC Medical Center | Los Angeles | California |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Medical College of Wisconsin Division of Trauma & Acute Care Surgery | Milwaukee | Wisconsin |
United States | St. Louis University Department of Surgery | Saint Louis | Missouri |
United States | The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery | San Antonio | Texas |
United States | University of Washington Harborview Medical Center Department of Surgery | Seattle | Washington |
United States | Baystate Medical Center Surgery Research, S3613 | Springfield | Massachusetts |
United States | Tampa General Hospital University of South Florida (USF) College of Medicine | Tampa | Florida |
United States | University of Arizona Department of Surgery | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Irrimax Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All Adverse Events | The primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). | up to 30 +/- 3 days | |
Secondary | Subjects With Device-Related Adverse Events | The secondary endpoint was identification of the number subjects with device-related adverse events from those that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). | up to 30 +/- 3 days | |
Secondary | Number of Device-Related Adverse Events | Another secondary endpoint was identification of the overall number device-related adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). | up to 30 +/- 3 days | |
Secondary | Number of Device Deficiencies | For the Irrisept group only, any device deficiencies identified in the medical records and/or source documents (during the closed study when the study device was used, even if the deficiency was not associated with an AE), was recorded. | up to 30 +/- 3 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05390125 -
Effectiveness of a Proficiency-based Progression Communication Training Programme
|
||
Completed |
NCT04012320 -
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
|
||
Completed |
NCT02268331 -
Comparison of Active vs. Passive Surveillance to Collect Adverse Events
|
N/A | |
Completed |
NCT00244673 -
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
|
Phase 4 | |
Recruiting |
NCT05038527 -
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
|
N/A | |
Completed |
NCT01291667 -
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE
|
Phase 3 | |
Completed |
NCT00681395 -
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
|
Phase 1 | |
Recruiting |
NCT05310344 -
Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer
|
Phase 2 | |
Recruiting |
NCT05311566 -
PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer
|
Phase 2 | |
Recruiting |
NCT05311579 -
Niraparib Plus Anlotinib for Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT05815615 -
Plasmapheresis: a Multi-modal Approach
|
N/A | |
Completed |
NCT02130570 -
Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
|
N/A | |
Recruiting |
NCT05804188 -
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
|
||
Not yet recruiting |
NCT06117176 -
Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
|
||
Recruiting |
NCT02725073 -
Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT02928705 -
Quality of Telemedically Guided Prehospital Analgesia
|
N/A | |
Withdrawn |
NCT01128127 -
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
|
N/A | |
Terminated |
NCT02011607 -
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
|
||
Completed |
NCT02310815 -
ReSure Sealant Post Approval Study
|
N/A | |
Recruiting |
NCT05709392 -
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
|
N/A |