Kidney StonesNCT00288457
Ureteral Stent Length and Patient Symptoms
An observational study of Kidney Stones, run by Emory University.
Trial summary
The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Ureteral Stent
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Oct 2006
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones
Inclusion Criteria: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones -
Exclusion Criteria:Under 18 years of age, inability to give informed consent
-
About this study
The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.
Read the detailed description
Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.
- Conditions
- Kidney Stones
- Being tested
- Ureteral Stent
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral StentDevice
Ureteral stents are not investigatory but rather part of standard of care. In this study, we were interested in having patients fill out pre and post-operative questionnaires so that we could compare their symptoms with the length of their ureter and the stent placed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionOct 2006
Why it stopped: Because no staff to consent or enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John G Pattaras, MD, Emory University
- Investigators
- John G Pattaras, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288457
- Sponsor's protocol ID
- 0758-2003
- Status last verified
- Dec 2013
- First submitted
- 6 Feb 2006
- Last updated
- 24 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stent Length and Patient Symptoms
- ClinicalTrials.gov ID
- NCT00288457
- Acronym / sponsor ID
- 0758-2003
- Conditions
- Kidney Stones
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because no staff to consent or enroll subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Feb 2006 (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 Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.
Detailed description
Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones
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 |
|---|---|---|
| Ureteral StentUreteral stents are not investigatory but rather part of standard of care. In this study, we were interested in having patients fill out pre and post-operative questionnaires so that we could compare their symptoms with the length of their ureter and the stent placed. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Because no staff to consent or enroll subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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.
John G Pattaras, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Because no staff to consent or enroll subjects). Results are not available in the source record.
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.
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 24 Dec 2013.