NCT01737645|TerminatedDMC
Study Stopped
Difficulty in enrolling subjects.
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Sponsor study identifier
observational
4
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2012
Actual (reported)August 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 29, 2012
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.
To determine rate of rise of IOP during steep Trendelenburg positioning
The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.
The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres)
BMI less than or equal to 30 kg/m2
Adult Subjects undergoing prolonged procedures expected to be in steep Trendelenburg position. Procedure must be scheduled for \> 3 hours, eg. robotic prostatectomy, hysterectomy, and cystectomy.
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Roy G Soto, MD
Corewell Health East
4 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2012
First Posted
November 29, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
July 17, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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