Retrospective Independent Safety Review of Closed Irrisept Study

Irrimax

Status: Completed

Conditions: Adverse Events

Treatments: Device: Standard of Care; Device: Irrisept

Study type: Interventional

Funder types: Industry

Identifiers

NCT05359666

CLP-01

Details and patient eligibility

About

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.

Full description

Between 2013 and 2016, Irrimax Corporation sponsored a prospective clinical study (IRR-CT-901-2013-01; NCT02255487) in the United States under IRB approval. IRR-CT-901-2013-01 defined primary and secondary efficacy, exploratory, and safety endpoints. The safety endpoint from IRR-CT-901-2013-01 was a clinical review and analysis of Adverse Events (AEs). However, IRR-CT-901-2013-01 was terminated early after the Interim Analysis primarily because of issues with the accuracy and completeness of the data collected for IRR-CT-901-2013-01, the lack of SoC standardization, and challenges assessing study endpoints arising out of the complexity of the trauma and co-morbidities of the subjects enrolled. The sole purpose of CLP-01 was to complete the safety endpoint for IRR-CT-901-2013-01.

CLP-01 reviewed all AEs recorded in IRR-CT-901-2013-01 and identified additional AEs in the subject source and medical records. All AEs were assessed for severity and causality and were reviewed by the individual Principal Investigators (PIs) at each site and the CLP-01 Medical Monitor (MM).

Enrollment: 592 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

592 participants in 2 patient groups

Irrisept

Experimental group

Description:

Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.

Treatment:

Device: Irrisept

Standard of Care (SoC)

Active Comparator group

Description:

Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.

Treatment:

Device: Standard of Care