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
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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) |
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 |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | May 2009 |
Estimated Study Completion Date : | June 2009 |
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female patients
- patients with ODS-Symptome-Score according Longo of >7
- existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
- patients who correspond to to the ASA 1 - ASA 2 criteria
Exclusion Criteria:
- male patients
- female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
- female patients with diarrhea
- pregnant patients because of the x-ray examination
- female patients who get anticoagulants
- serious cardiopulmonary disorders
- disorders of the blood coagulation
- female patients who correspond to the ASA 3 to ASA 4 criteria

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 6607668922 | info@auau.at |
Austria | |
St. Elisabeth Hospital | Recruiting |
Vienna, Austria, A-1220 | |
Contact: Michaela Abrahamowicz, Dr. med. 01143 1 71126 ext 29 info@auau.at | |
Principal Investigator: Michaela Abrahamowicz, Dr. med. |
Principal Investigator: | Michaela Abrahamowicz, Dr. med. |
Responsible Party: | Gerhard Pejcl/Director, Gerhard Pejcl Medizintechnik GmbH |
ClinicalTrials.gov Identifier: | NCT00836680 History of Changes |
Other Study ID Numbers: |
GPejcl-230109 |
First Posted: | February 4, 2009 Key Record Dates |
Last Update Posted: | February 4, 2009 |
Last Verified: | February 2009 |
Additional relevant MeSH terms:
Hernia Prolapse Rectal Prolapse Hernia, Abdominal Pathological Conditions, Anatomical |
Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Pelvic Organ Prolapse |