Study Results
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Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2012-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be ≥ 18 years of age.
* Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy.
* Subjects must be able understand and willing to sign a written informed consent form.
Exclusion Criteria
* Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis.
* Subjects with prior endometrial ablation procedures.
* Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.
18 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Israel Zighelboim, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
References
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Related Links
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Alvin J.Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201102405
Identifier Type: -
Identifier Source: org_study_id
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