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Comparison of Fluid Capture Efficiency of the Total Capture Drape Versus a Standard Drape for Hysteroscopy

NCT04540952 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-04-21

Study results available
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Summary

Safety during operative hysteroscopy requires a fluid management system to assist in gauging patient fluid absorption of media used for visualizing the uterine cavity. Serious patient complications, including hyponatremia (low serum sodium), heart failure, and pulmonary and cerebral edema, can result from over absorption of this distending medium. Failure of surgical drapes to collect unabsorbed fluid causes inaccurate determination of the hysteroscopic fluid deficit (HD) thus preventing proper risk evaluation for patient fluid overload, could prompt premature procedure terminatio, and result in hazards for the OR team.

Specific Aims:

1. To perform a comparative trial of the "Total Capture" hysteroscopy drape (TCD) versus the standard drape during patient surgeries to document improved, real-time determination of patient fluid absorption. Pilot testing of a prototype design of the "Total Capture drape" versus the conventional hysteroscopy drape indicated remarkable improvement in fluid capture and accurate fluid deficit determination in a plastic pelvic model experiment.
2. To evaluate the clinical usefulness of the TCD compared to the Standard drape for hysteroscopy with the standardized metrics of: 1) the Technology Acceptance Model, and 2) The System Usability Scale. These metrics will allow us to quantitate clinical usefulness and usability of both the operating surgeons and operating room staff.

The investigators hypothesize the "Total Capture" Drape design provides an accurate recorded hysteroscopic fluid deficit in real-time so that patient safety and surgical parameters are optimized. The simple design of the TCD would add a very significant improvement for patient safety and care with minimal cost for the estimated 200,000 hysteroscopies performed per year in the U.S.

Conditions

  • Hysteroscopic Surgery

Interventions

DEVICE

Total Capture Drape

Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure

DEVICE

Standard Hysteroscopy Drape

Standard surgical drape used to adequately collect fluid during hysteroscopy procedure

Sponsors & Collaborators

  • North Carolina Biotechnology Center

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Paul B. Marshburn, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2020-03-10
Completion
2020-03-10
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 NCT04540952 on ClinicalTrials.gov