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Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact

NCT05545956 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-24

No results posted yet for this study

Summary

The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.

Conditions

  • Blood Recovery

Interventions

PROCEDURE

Hand Wrung

Hand wrung refers to manually wringing surgical sponges by hand.

DEVICE

ProCell Wrung

ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Sponsors & Collaborators

  • ProCell Surgical Inc.

    collaborator UNKNOWN

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Marc Pelletier, MD · University Hospitals Cleveland Medical Center

  • Craig Jarrett, MD, MBA · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2025-01-01
Completion
2025-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05545956 on ClinicalTrials.gov