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Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface

NCT03573557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2022-03-23

No results posted yet for this study

Summary

To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.

Conditions

  • Vaginal Surgery
  • Laparoscopic Surgery

Interventions

DEVICE

Pink Pad

Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.

DEVICE

Bean Bag

Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.

DEVICE

Gel Pad

Gel Pad used for patients in steep Trendelenburg position during surgery.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sherif El-Nashar, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-12-17
Completion
2019-12-17

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 NCT03573557 on ClinicalTrials.gov