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

NCT04540952 | Terminated Results FDA Device

• 1 other identifier: 04-16-07B
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Hysteroscopic Surgery

Keywords

hysteroscopy; fluid management; safety; surgical complications; surgical drape

Outcome Measures

Primary Outcomes (1)

• Hysteroscopic Fluid Deficit (HFD) Measured by the Fluid Management System by Subtracting the Outflow Volume (OV) Returned to the Fluid Management System From the Inflow Volume (IV).

  Surgery duration, and average of 30 minutes was used to measure hysteroscopic fluid deficit measured by the fulid management system by subtracting the outflow volume returned to the fluid management system from the inflow volume.

  Surgery Duration

Secondary Outcomes (2)

• Number of Participants With Uncollected Distention Fluid Volume Found on Operating Room Floor and Bedding

  Surgery Duration

• Number of Participants With Hysteroscopy Fluid Management Alarm Activation

  1 day (day of procedure)

Study Arms (2)

Total Capture Drape

EXPERIMENTAL

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

Device: Total Capture Drape

Control

ACTIVE COMPARATOR

Standard surgical drape used to adequately collect fluid during hysteroscopy procedure

Device: Standard Hysteroscopy Drape

Interventions

Total Capture Drape DEVICE

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

Total Capture Drape

Standard Hysteroscopy Drape DEVICE

Standard surgical drape used to adequately collect fluid during hysteroscopy procedure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are scheduled for a hysteroscopy that require a fluid management system at an Atrium Health operating room facility.

You may not qualify if:

• Women will be excluded if they are not acceptable candidates for a hysteroscopy procedure for any reason.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• North Carolina Biotechnology Center: collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Limitations and Caveats

We had to stop enrolling due to COVID-19 so the numbers are lower than expected.

Results Point of Contact

• Title: Dr. Paul Marshburn
• Organization: Atrium Health

Paul.Marshburn@atriumhealth.org

704-619-2537

Study Officials

• Paul B. Marshburn, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomization of patients without their knowledge of grouping. Surgical providers become aware of randomized drape selection only at the time of hysteroscopy. Principal investigator blinded to selection and results.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Early Clinical Trial

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: September 7, 2020
• Study Start: January 9, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: April 21, 2022
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)