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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michaela Abrahamowicz, Dr. med. | Contact | 01143 6607668922 | info@auau.at |
| Name | Affiliation | Role |
|---|---|---|
| Michaela Abrahamowicz, Dr. med. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elisabeth Hospital | Recruiting | Vienna | State of Vienna | A-1220 | Austria |
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