Clinical Trial: 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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Detailed Summary: 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.
Sponsor: Gerhard Pejcl Medizintechnik GmbH

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Gerhard Pejcl Medizintechnik GmbH

Dates:
Date Received: January 23, 2009
Date Started: January 2009
Date Completion: June 2009
Last Updated: February 2, 2009
Last Verified: February 2009