Ureteral StrictureNCT03794102
Water Versus Saline as Irrigation Fluid for Ureteroscopy
A study testing Water and Saline in people with Ureteral Stricture and Hydronephrosis, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. The investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stricture, Hydronephrosis, Urothelial Carcinoma
- What is being tested?
- Water and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2017to 30 Jun 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Participants meeting medical requirements to undergo ureteroscopy
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System
Atlanta, Georgia, 30303
Emory University
Atlanta, Georgia, 30322
About this study
Official title: The Effects of Water Versus Saline on Absorption Rates and Visualization During Ureteroscopy
The purpose of this study is to determine the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. The investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used.
Read the detailed description
The use of fluid irrigation is important during urologic procedures. There is little research done on the use of water versus saline for irrigation during ureteroscopy.
This study will evaluate whether the use of water or saline during ureteroscopy has any clinical implications. The investigators will compare the amount of fluid absorbed and differences in electrolytes between the two participant groups.
- Conditions
- Ureteral Stricture, Hydronephrosis, Urothelial Carcinoma, Urolithiasis
- Being tested
- Water, Saline
- Medical subject headings
- Hydronephrosis, Carcinoma, Transitional Cell, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Sterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
SalineOther
0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ureteroscopy with water irrigation | Active comparator | Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Water will be used as the irrigation fluid during the ureteroscopy. Receives: Other: Water |
| Ureteroscopy with saline irrigation | Active comparator | Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Saline will be used as the irrigation fluid during the ureteroscopy. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of irrigation fluid used during ureteroscopy
At conclusion of the ureteroscopy, the bag with the remaining fluid will be weighed to determine amount of fluid used. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Measured: Measurement will be performed day of ureteroscopy
Change in serum sodium levels
Blood samples will be drawn preoperatively and at conclusion of case (prior to awakening the participant) to assess the serum sodium levels (mEq/L). The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Measured: Measurement will be performed day of ureteroscopy
Surgeon's rating of ureteroscopic visualization
The surgeon will be asked to rate the degree of ureteroscopic visualization on a scale of 1-5, where 1=Poor visualization and 5= Excellent visualization. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Measured: Measurement will be performed day of ureteroscopy
Measurement of fluid clarity
Fluid clarity was assessed by taking turbidity (cloudiness) measurements of renal fluid (in nephelometric turbidity units (NTU)) with a turbidimeter. The average of three measurements of turbidity was used at the fluid clarity measurement of each case, to supplement the ureteroscopic visualization measurement by surgeon rating. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Measured: Measurement will be performed day of ureteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start17 Jan 2017
- Primary completion22 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Ogan, MD, Emory University
- Investigators
- Kenneth Ogan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794102
- Sponsor's protocol ID
- IRB00005780
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Water Versus Saline on Absorption Rates and Visualization During Ureteroscopy
- ClinicalTrials.gov ID
- NCT03794102
- Acronym / sponsor ID
- IRB00005780
- Conditions
- Ureteral Stricture, Hydronephrosis, Urothelial Carcinoma, Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 4 Jan 2019 (actual)
- 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 the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. The investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used.
Detailed description
The use of fluid irrigation is important during urologic procedures. There is little research done on the use of water versus saline for irrigation during ureteroscopy.
This study will evaluate whether the use of water or saline during ureteroscopy has any clinical implications. The investigators will compare the amount of fluid absorbed and differences in electrolytes between the two participant groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteroscopy with water irrigation | Active comparator | Other: WaterParticipants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Water will be used as the irrigation fluid during the ureteroscopy. |
| Ureteroscopy with saline irrigation | Active comparator | Other: SalineParticipants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Saline will be used as the irrigation fluid during the ureteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years of age
- Participants meeting medical requirements to undergo ureteroscopy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| WaterSterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure. | Other | Ureteroscopy with water irrigation |
| Saline0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure. | Other | Ureteroscopy with saline irrigation |
Primary outcome
Amount of irrigation fluid used during ureteroscopy
Time frame: Measurement will be performed day of ureteroscopy
At conclusion of the ureteroscopy, the bag with the remaining fluid will be weighed to determine amount of fluid used. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Change in serum sodium levels
Time frame: Measurement will be performed day of ureteroscopy
Blood samples will be drawn preoperatively and at conclusion of case (prior to awakening the participant) to assess the serum sodium levels (mEq/L). The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Surgeon's rating of ureteroscopic visualization
Time frame: Measurement will be performed day of ureteroscopy
The surgeon will be asked to rate the degree of ureteroscopic visualization on a scale of 1-5, where 1=Poor visualization and 5= Excellent visualization. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
Measurement of fluid clarity
Time frame: Measurement will be performed day of ureteroscopy
Fluid clarity was assessed by taking turbidity (cloudiness) measurements of renal fluid (in nephelometric turbidity units (NTU)) with a turbidimeter. The average of three measurements of turbidity was used at the fluid clarity measurement of each case, to supplement the ureteroscopic visualization measurement by surgeon rating. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
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 4 Jan 2019.
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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.
Kenneth Ogan, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and Saline in people with Ureteral Stricture and Hydronephrosis, run by Emory University at 2 sites in United States.
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 2 inclusion and 1 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 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Amount of irrigation fluid used during ureteroscopy (time frame: Measurement will be performed day of ureteroscopy). The study lists 4 primary outcomes in all. 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 Jan 2019.