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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00836680 |
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Date of registration:
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23/01/2009 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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January 2009 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00836680 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Contacts
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Name:
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Michaela Abrahamowicz, Dr. med. |
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Address:
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Telephone:
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01143 1 71126 |
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Email:
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info@auau.at |
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Affiliation:
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Name:
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Michaela Abrahamowicz, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Michaela Abrahamowicz, Dr. med. |
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Address:
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Telephone:
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01143 6607668922 |
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Email:
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info@auau.at |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Internal Hernia Into the Douglas Pouch
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Internal Rectal Prolapse
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Pelvic Floor Ptosis
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Intervention(s)
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Device: Colorectal Stent
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Secondary ID(s)
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GPejcl-230109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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