Ureteral CalculiNCT00517205
Study on 'The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcomes of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter'
An observational study of Ureteral Calculi, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of this research is to assess the role of non-contrast helical computerized tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock wave lithotripsy (ESWL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- Non-contrast helical computerized tomogram (NCHCT)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2004to Dec 2007
- 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
- Adult, Older adult
Study population: Patient suffered upper ureteric stone
Who may be able to join
- Adult patient (> 18 years old)
- With solitary upper ureteric stone (defined as ureter above the sacroiliac joint as seen on plain radiography) diagnosed by NCHCT *(* can have stones at the other site but the indexed stone is a solitary stone)
- Size 5 to 15 mm in the maximal diameter as measured from plain radiography.
- Planned for primary in-situ ESWL
Who cannot join
- Patient contraindicated for ESWL - active urosepsis, coagulopathy, pregnant lady etc
- Presence of percutaneous nephrostomy or ureteric stent
- Suspected distal obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcome of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter
The purpose of this research is to assess the role of non-contrast helical computerized tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock wave lithotripsy (ESWL).
- Conditions
- Ureteral Calculi
- Being tested
- Non-contrast helical computerized tomogram (NCHCT)
- Keywords
- upper ureteric stone
- Medical subject headings
- Ureteral Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast helical computerized tomogram (NCHCT)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startOct 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Chi Fai Ng, Dr, Principal investigator, Department of Surgery, Division of Urology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517205
- Sponsor's protocol ID
- CRE-2004.309
- Other IDs
- HARECCTR0500008
- Status last verified
- Jun 2011
- First submitted
- 15 Aug 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcome of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter
- ClinicalTrials.gov ID
- NCT00517205
- Acronym / sponsor ID
- CRE-2004.309
- Conditions
- Ureteral Calculi
- Keywords
- upper ureteric stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Oct 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Aug 2007 (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 research is to assess the role of non-contrast helical computerized tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock wave lithotripsy (ESWL).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient suffered upper ureteric stone
Key inclusion criteria (4 listed)
- Adult patient (> 18 years old)
- With solitary upper ureteric stone (defined as ureter above the sacroiliac joint as seen on plain radiography) diagnosed by NCHCT *(* can have stones at the other site but the indexed stone is a solitary stone)
- Size 5 to 15 mm in the maximal diameter as measured from plain radiography.
- Planned for primary in-situ ESWL
Key exclusion criteria (3 listed)
- Patient contraindicated for ESWL - active urosepsis, coagulopathy, pregnant lady etc
- Presence of percutaneous nephrostomy or ureteric stent
- Suspected distal obstruction
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 |
|---|---|---|
| Non-contrast helical computerized tomogram (NCHCT) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 16 Jun 2011.
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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.
Chi Fai Ng, Dr principal investigator
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Calculi, run by Hospital Authority, Hong Kong at 1 site in China.
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 3 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 16 Jun 2011. 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 China. 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.
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 16 Jun 2011.