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

February 2, 2009 updated by: Gerhard Pejcl Medizintechnik GmbH

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1220
        • Recruiting
        • St. Elisabeth Hospital
        • Contact:
          • Michaela Abrahamowicz, Dr. med.
          • Phone Number: 29 01143 1 71126
          • Email: info@auau.at
        • Principal Investigator:
          • Michaela Abrahamowicz, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerhard Pejcl Medizintechnik GmbH

Investigators

  • Principal Investigator: Michaela Abrahamowicz, Dr. med.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2009

Study Completion (ANTICIPATED)

June 1, 2009

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (ESTIMATE)

February 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPejcl-230109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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