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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
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Gerhard Pejcl Medizintechnik GmbH.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Gerhard Pejcl Medizintechnik GmbH
Information provided by:
Gerhard Pejcl Medizintechnik GmbH
ClinicalTrials.gov Identifier:
NCT00836680
First received: January 23, 2009
Last updated: February 2, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
| Internal Rectal Prolapse Pelvic Floor Ptosis Internal Hernia Into the Douglas Pouch | Device: Colorectal Stent |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Gerhard Pejcl Medizintechnik GmbH:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 15 |
| 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) |
Intervention Details:
Detailed Description:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836680
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836680
Contacts
| Contact: Michaela Abrahamowicz, Dr. med. | 01143 6607668922 | info@auau.at |
Locations
| 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. | |
Sponsors and Collaborators
Gerhard Pejcl Medizintechnik GmbH
Investigators
| Principal Investigator: | Michaela Abrahamowicz, Dr. med. |
More Information
| Responsible Party: | Gerhard Pejcl/Director, Gerhard Pejcl Medizintechnik GmbH |
| ClinicalTrials.gov Identifier: | NCT00836680 History of Changes |
| Other Study ID Numbers: |
GPejcl-230109 |
| Study First Received: | January 23, 2009 |
| Last Updated: | February 2, 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 |
ClinicalTrials.gov processed this record on June 23, 2017