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
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|ClinicalTrials.gov Identifier: NCT00836680|
Recruitment Status : Unknown
Verified February 2009 by Gerhard Pejcl Medizintechnik GmbH.
Recruitment status was: Recruiting
First Posted : February 4, 2009
Last Update Posted : February 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|Internal Rectal Prolapse Pelvic Floor Ptosis Internal Hernia Into the Douglas Pouch||Device: Colorectal Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||June 2009|
- Device: Colorectal Stent
Diagnosis of an internal rectal prolapse:
The device will be introduced and placed into the patient via a proctoscopic procedure. After that the doctor can measure and determine the internal rectal prolapse. After the diagnosis results have been received, the device will be removed from the patient via proctoscopic examination. The whole procedure will take approx. 5 minutes.
An additional X-ray examination procedure with the use of contrast media will be made for the determination of a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.
- Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch. [ Time Frame: 4 months ]
- Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836680
|Contact: Michaela Abrahamowicz, Dr. med.||01143 firstname.lastname@example.org|
|St. Elisabeth Hospital||Recruiting|
|Vienna, Austria, A-1220|
|Contact: Michaela Abrahamowicz, Dr. med. 01143 1 71126 ext 29 email@example.com|
|Principal Investigator: Michaela Abrahamowicz, Dr. med.|
|Principal Investigator:||Michaela Abrahamowicz, Dr. med.|