Ureteral ObstructionNCT06110299
Room Air a Safe Alternative to Dye Injection in Ureterography
A study testing air injection in people with Ureteral Obstruction, run by Assiut University.
Trial summary
The procedure began in the Thirties .Retrograde pyelography is an essential step in most endoscopic procedure. This procedure is used as an investigation, with different indication in the past and the present, to delineate the ureter and pelvicalyceal system either before or after the operation, for example to detect… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureteral Obstruction
- What is being tested?
- air injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2023to 29 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing Urs
Who cannot join
- no
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Room Air vs Iohexol Injection in URS
The procedure began in the Thirties .Retrograde pyelography is an essential step in most endoscopic procedure. This procedure is used as an investigation, with different indication in the past and the present, to delineate the ureter and pelvicalyceal system either before or after the operation, for example to detect any complication as a perforation and the need for stent placement. The procedure has an alternative, less invasive, the IVP. Multiple articles explored the use of air in the puncture of PCNL and to identify the posterior calyx, but to our knowledge there is no articles addressed the idea of air injection in the ureter. The greatest fear is air embolism or non-visualization of the ureter. The availability and cost of contrast material may be a problem, most urologist face
Read the detailed description
Our aim is to explore the feasibility of using Room air as a contrast material and check the safety of this procedure.
Materials and methods:
A pilot study in Assiut university hospital Urology department to evaluate the efficacy of air injection as a replacement dye injection in cases of endoscopy either in emergency or elective situation. Twenty patients were selected randomly, to evaluate the impact of retrograde pyelography (RPG) using air in cases of obstructed ureters and raised renal function.
- Conditions
- Ureteral Obstruction
- Being tested
- air injection
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air injectionDiagnostic test
delination of the ureter and pelvis by injecting air under C-ARM
| Study group | Role | What they receive |
|---|---|---|
| patients with obstructed ureters | Experimental | Not described Receives: Diagnostic Test: air injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
no air embolism
Measured: 3 months
Secondary outcomes (1)
identification of ureter
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start29 Oct 2023 (estimated)
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110299
- Sponsor's protocol ID
- delination of PCS by air
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gupta P, Choudhary GR, Pandey H, Madduri VKS, Singh M, Pallagani L. Air vs contrast pyelogram for initial puncture access in percutaneous nephrolithotomy: a randomized controlled trial. Urolithiasis. 2021 Jun;49(3):261-267. doi: 10.1007/s00240-020-01222-6. Epub 2020 Nov 7.
PubMed 33159536Sharma AK, Sharma S, Swain S, Goel G, Gujela A, Hota D, Mohapatra B, Sharma B. A comparative study of air pyelogram and contrast pyelogram for initial puncture access and to see its efficacy during percutaneous nephrolithotomy. Urol Ann. 2022 Oct-Dec;14(4):340-344. doi: 10.4103/ua.ua_80_21. Epub 2022 Sep 7.
PubMed 36505991Jangid DK, Sharma G, Yadav SS, Tomar V, Mathur R. A Comparative Study of Antegrade Air Pyelogram and Retrograde Air Pyelogram for Initial Puncture Access during Percutaneous Nephrolithotomy. J Clin Diagn Res. 2017 Apr;11(4):PC01-PC03. doi: 10.7860/JCDR/2017/24821.9724. Epub 2017 Apr 1.
PubMed 28571203Garg A, Ali Khan MM, Singh P, Agarwal MK. Air embolism during percutaneous nephrolithotomy using air pyelogram during initial access: Does it really occur? Urol Ann. 2020 Jan-Mar;12(1):54-56. doi: 10.4103/UA.UA_10_19. Epub 2019 Nov 7.
PubMed 32015618Lipkin ME, Mancini JG, Zilberman DE, Raymundo ME, Yong D, Ferrandino MN, Miller MJ, Yoshizumi TT, Preminger GM. Reduced radiation exposure with the use of an air retrograde pyelogram during fluoroscopic access for percutaneous nephrolithotomy. J Endourol. 2011 Apr;25(4):563-7. doi: 10.1089/end.2010.0431. Epub 2011 Mar 22.
PubMed 21426236
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Room Air vs Iohexol Injection in URS
- ClinicalTrials.gov ID
- NCT06110299
- Acronym / sponsor ID
- delination of PCS by air
- Conditions
- Ureteral Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Oct 2023 (estimated)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 31 Oct 2023 (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 procedure began in the Thirties .Retrograde pyelography is an essential step in most endoscopic procedure. This procedure is used as an investigation, with different indication in the past and the present, to delineate the ureter and pelvicalyceal system either before or after the operation, for example to detect any complication as a perforation and the need for stent placement. The procedure has an alternative, less invasive, the IVP. Multiple articles explored the use of air in the puncture of PCNL and to identify the posterior calyx, but to our knowledge there is no articles addressed the idea of air injection in the ureter. The greatest fear is air embolism or non-visualization of the ureter. The availability and cost of contrast material may be a problem, most urologist face
Detailed description
Our aim is to explore the feasibility of using Room air as a contrast material and check the safety of this procedure.
Materials and methods:
A pilot study in Assiut university hospital Urology department to evaluate the efficacy of air injection as a replacement dye injection in cases of endoscopy either in emergency or elective situation. Twenty patients were selected randomly, to evaluate the impact of retrograde pyelography (RPG) using air in cases of obstructed ureters and raised renal function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with obstructed ureters | Experimental | Diagnostic Test: air injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing Urs
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| air injectiondelination of the ureter and pelvis by injecting air under C-ARM | Diagnostic test | patients with obstructed ureters |
Primary outcome
no air embolism
Time frame: 3 months
1 secondary outcome
identification of ureter
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 33159536Gupta P, Choudhary GR, Pandey H, Madduri VKS, Singh M, Pallagani L. Air vs contrast pyelogram for initial puncture access in percutaneous nephrolithotomy: a randomized controlled trial. Urolithiasis. 2021 Jun;49(3):261-267. doi: 10.1007/s00240-020-01222-6. Epub 2020 Nov 7.
- Background: PubMed 36505991Sharma AK, Sharma S, Swain S, Goel G, Gujela A, Hota D, Mohapatra B, Sharma B. A comparative study of air pyelogram and contrast pyelogram for initial puncture access and to see its efficacy during percutaneous nephrolithotomy. Urol Ann. 2022 Oct-Dec;14(4):340-344. doi: 10.4103/ua.ua_80_21. Epub 2022 Sep 7.
- Background: PubMed 28571203Jangid DK, Sharma G, Yadav SS, Tomar V, Mathur R. A Comparative Study of Antegrade Air Pyelogram and Retrograde Air Pyelogram for Initial Puncture Access during Percutaneous Nephrolithotomy. J Clin Diagn Res. 2017 Apr;11(4):PC01-PC03. doi: 10.7860/JCDR/2017/24821.9724. Epub 2017 Apr 1.
- Background: PubMed 32015618Garg A, Ali Khan MM, Singh P, Agarwal MK. Air embolism during percutaneous nephrolithotomy using air pyelogram during initial access: Does it really occur? Urol Ann. 2020 Jan-Mar;12(1):54-56. doi: 10.4103/UA.UA_10_19. Epub 2019 Nov 7.
- Background: PubMed 21426236Lipkin ME, Mancini JG, Zilberman DE, Raymundo ME, Yong D, Ferrandino MN, Miller MJ, Yoshizumi TT, Preminger GM. Reduced radiation exposure with the use of an air retrograde pyelogram during fluoroscopic access for percutaneous nephrolithotomy. J Endourol. 2011 Apr;25(4):563-7. doi: 10.1089/end.2010.0431. Epub 2011 Mar 22.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing air injection in people with Ureteral Obstruction, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelrahman M abdelkader (01068336396, abdelrahmanmohamed.aa@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no air embolism (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110299, which also lists 5 linked publications.
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 31 Oct 2023.