Status:
UNKNOWN
Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
Lead Sponsor:
Gerhard Pejcl Medizintechnik GmbH
Conditions:
Internal Rectal Prolapse
Pelvic Floor Ptosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal herni...
Detailed Description
Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients....
Eligibility Criteria
Inclusion
- female patients
- patients with ODS-Symptome-Score according Longo of \>7
- existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
- patients who correspond to to the ASA 1 - ASA 2 criteria
Exclusion
- male patients
- female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
- female patients with diarrhea
- pregnant patients because of the x-ray examination
- female patients who get anticoagulants
- serious cardiopulmonary disorders
- disorders of the blood coagulation
- female patients who correspond to the ASA 3 to ASA 4 criteria
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00836680
Start Date
January 1 2009
End Date
June 1 2009
Last Update
February 4 2009
Active Locations (1)
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1
St. Elisabeth Hospital
Vienna, Vienna, Austria, A-1220