Urologic DiseasesNCT02622269
Patient-driven Compression in Urography
A study testing Patient-regulated compression device and Standard compression device in people with Urologic Diseases, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression. Evaluation of radiation dose, image quality and patients' experiences Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Patient-regulated compression device and Standard compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to Jan 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with a request for a urographic study
Who cannot join
- Emergency studies,
- cannot participate actively with compression,
- contraindications to compression of the abdomen,
- pregnancy,
- inability to understand the language of the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.
Evaluation of radiation dose, image quality and patients' experiences
Read the detailed description
Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.
Two compression devices are investigated in each patient, in randomized order.
Aims of the study:
- Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
- Evaluate image quality with the two devices.
- Describe patients' experiences from using the two devices.
- Conditions
- Urologic Diseases
- Being tested
- Patient-regulated compression device, Standard compression device
- Keywords
- Urography, Radiation dosage, image enhancement
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-regulated compression deviceDevice
Compression of the abdomen with a patient-regulated compression device
Standard compression deviceDevice
Compression of the abdomen with the standard compression device
| Study group | Role | What they receive |
|---|---|---|
| Patient-regulated compression | Experimental | Patient-regulated compression device Receives: Device: Patient-regulated compression device |
| Standard compression | Active comparator | Standard compression device Receives: Device: Standard compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose measured as Dose-area product
Radiation dose for the investigated exposures, measured as Dose-area product
Measured: Immediately
Secondary outcomes (2)
Image quality measured with Visual Grading
Image quality for the investigated images, measured with Visual Grading
Measured: Immediately
Patient experience (questionnaire)
A questionnaire will be analysed with qualitative content analysis
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkan Geijer, Örebro University, Sweden
- Investigators
- Håkan Geijer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622269
- Sponsor's protocol ID
- 183781
- Status last verified
- Feb 2016
- First submitted
- 2 Dec 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-driven Compression in Urography
- ClinicalTrials.gov ID
- NCT02622269
- Acronym / sponsor ID
- 183781
- Conditions
- Urologic Diseases
- Keywords
- Urography, Radiation dosage, image enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Dec 2015 (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.
Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.
Evaluation of radiation dose, image quality and patients' experiences
Detailed description
Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.
Two compression devices are investigated in each patient, in randomized order.
Aims of the study:
- Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
- Evaluate image quality with the two devices.
- Describe patients' experiences from using the two devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-regulated compression | Experimental | Device: Patient-regulated compression devicePatient-regulated compression device |
| Standard compression | Active comparator | Device: Standard compression deviceStandard compression device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with a request for a urographic study
Key exclusion criteria (5 listed)
- Emergency studies,
- cannot participate actively with compression,
- contraindications to compression of the abdomen,
- pregnancy,
- inability to understand the language of the questionnaire
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 |
|---|---|---|
| Patient-regulated compression deviceCompression of the abdomen with a patient-regulated compression device | Device | Patient-regulated compression |
| Standard compression deviceCompression of the abdomen with the standard compression device | Device | Standard compression |
Primary outcome
Radiation dose measured as Dose-area product
Time frame: Immediately
Radiation dose for the investigated exposures, measured as Dose-area product
2 secondary outcomes
Image quality measured with Visual Grading
Time frame: Immediately
Patient experience (questionnaire)
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Urologic Diseases
Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Bladder Cancer, TURBT
RecruitingPhase 3
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Bladder Cancer
RecruitingPhase 1/2
Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
Advanced Cancer, Clear Cell Renal Cell Carcinoma
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
RecruitingPhase 2
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
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.
Håkan Geijer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-regulated compression device and Standard compression device in people with Urologic Diseases, run by Örebro University, Sweden at 1 site in Sweden.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 25 Feb 2016. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose measured as Dose-area product (time frame: Immediately). 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 25 Feb 2016.