Status:
WITHDRAWN
Photoacoustic Endoscopy in Endometrial Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Endometrial Cancer
Benign Neoplasm of Body of Uterus
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to evaluate whether a new technology called intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the uterus.
Detailed Description
The investigators will evaluate whether this technology can be used and also try to obtain photoacoustic images and functional data (oxygen contents, blood vessel characteristics, etc) of the uterine ...
Eligibility Criteria
Inclusion
- Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy.
- 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
- Subjects with contraindications for general anesthesia or hysterectomy.
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01498237
Start Date
January 1 2012
End Date
December 1 2012
Last Update
July 11 2013
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