NCT03573557

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

June 15, 2018

Last Update Submit

March 22, 2022

Conditions

Vaginal SurgeryLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Length of displacement when in Trendelenburg

    Normal amount of displacement when place in Trendelenburg

    1 day

Secondary Outcomes (10)

  • Cost of device

    1 day

  • Rank of ease of use by physician

    1 day

  • Number of adverse events

    1 day

  • Erythema score

    1 day

  • Patient BMI

    1 day

  • +5 more secondary outcomes

Study Arms (3)

Pink Pad

ACTIVE COMPARATOR

The Pink Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure.

Device: Pink Pad

Bean Bag

ACTIVE COMPARATOR

The Bean Bag will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure.

Device: Bean Bag

Gel Pad

ACTIVE COMPARATOR

The Gel Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg determine how much slipping is happening during the procedure.

Device: Gel Pad

Interventions

Pink PadDEVICE

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

Pink Pad
Bean BagDEVICE

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

Bean Bag
Gel PadDEVICE

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

Gel Pad

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
  • Patients must not be pregnant

You may not qualify if:

  • Pregnancy
  • Patients unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

  • Sherif El-Nashar, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 29, 2018

Study Start

June 5, 2018

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

US(1)