Internal Rectal ProlapseNCT00836680
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
A study testing Colorectal Stent in people with Internal Rectal Prolapse and Pelvic Floor Ptosis, run by Gerhard Pejcl Medizintechnik GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Internal Rectal Prolapse, Pelvic Floor Ptosis, Internal Hernia Into the Douglas Pouch
- What is being tested?
- Colorectal Stent
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
St. Elisabeth Hospital
Vienna, State of Vienna, A-1220
Michaela Abrahamowicz, Dr. med., 01143 1 71126 ext. 29, info@auau.at
Michaela Abrahamowicz, Dr. med.
About this study
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
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.
Read the 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.
- Being tested
- Colorectal Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal StentDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerhard Pejcl Medizintechnik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michaela Abrahamowicz, Dr. med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836680
- Sponsor's protocol ID
- GPejcl-230109
- Status last verified
- Feb 2009
- First submitted
- 23 Jan 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00836680
- Acronym / sponsor ID
- GPejcl-230109
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Gerhard Pejcl Medizintechnik GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal StentDiagnosis 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. | Device | – |
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
1 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Abrahamowicz, Dr. med. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal Stent in people with Internal Rectal Prolapse and Pelvic Floor Ptosis, run by Gerhard Pejcl Medizintechnik GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michaela Abrahamowicz, Dr. med. (01143 6607668922, info@auau.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.