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
Recruitment status was Recruiting
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.
Internal Rectal Prolapse
Pelvic Floor Ptosis
Internal Hernia Into the Douglas Pouch
Device: Colorectal Stent
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|