An interventional study of Colorectal Stent in Internal Rectal Prolapse, Pelvic Floor Ptosis and Internal Hernia Into the Douglas Pouch, sponsored by Gerhard Pejcl Medizintechnik GmbH. Status unknown at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-04.
Sponsored by Gerhard Pejcl Medizintechnik GmbH · Not applicable, Interventional, and Treatment
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 hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.
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. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.
54 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 15 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →This is the only study on the registry with Gerhard Pejcl Medizintechnik GmbH as lead sponsor.
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Exclusion Criteria:
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
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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