Photoacoustic Endoscopy in Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT01498237|
Recruitment Status : Withdrawn (Need to obtain IDE prior to commencement of study)
First Posted : December 23, 2011
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Benign Neoplasm of Body of Uterus||Device: Photoacoustic endoprobe Procedure: Photoacoustic endoscopy||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: Photoacoustic endoscopy
This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
Device: Photoacoustic endoprobe
The PAE assessment will be performed in the operating room following strict sterile technique. PAE is performed immediately prior to the planned surgery. Participants are prepped following standard protocol. Length of the endometrial cavity is determined by a uterine sound. Endocervix is dilated as needed to allow passage of the PAE probe. The PAE probe will be advanced to the uterine fundus. Images will be obtained during withdrawal of the PAE probe from fundus to the os. Recorded images will allow computer assisted image analysis and functional measurements to be performed. Duration and difficulty of the procedure will be recorded. Comments and complications will be specifically noted.
Other Name: There are no other interventions.Procedure: Photoacoustic endoscopy
Photoacoustic endoscopy probe will be inserted into the endometrial canal to the uterine fundus and images will be obtained during the withdrawal of the probe from the fundus to the endocervical os.
Other Name: There are no other interventions.
- Feasibility of using the device to image endometrial cancer [ Time Frame: 12 months or less ]Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498237
|Principal Investigator:||Israel Zighelboim, MD||Washington University School of Medicine|