Ureteropelvic Junction ObstructionPhase 3NCT05895422
Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO
A Phase 3 study testing pyeloplasty in people with Ureteropelvic Junction Obstruction, run by Cairo University at 1 site in Egypt.
Trial summary
an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteropelvic Junction Obstruction
- What is being tested?
- pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jul 2025
- Phase
- Phase 3
- 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
- all patients with UPJO above 18 years
- UPJO caused by crossing vessels confirmed by CT angiography
- Symptomatic UPJO
Who cannot join
- recurrent UPJO after a previous trial of open repair ,
- secondary UPJO after open renal surgery.
- UPJO in non functioning kidney
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Cairo, 115
Ahmed M Rammah, MD, 2001005622939, ahmedrammah2013@gmail.com
Islam N Abdel AZIA, M.sc, 2001013132994, islamnasser54asdasd@gmail.com
About this study
Official title: Functional Outcome After Laparoscopic and Robot Assisted Management of Uretero-pelvic Junction Obstruction Disease Caused by Crossing Vessels for Adult Patients
an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.
Read the detailed description
in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.
- Conditions
- Ureteropelvic Junction Obstruction
- Being tested
- pyeloplasty
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyeloplastyProcedure or surgery
repair of the uPJO
| Study group | Role | What they receive |
|---|---|---|
| vascular hitch | Experimental | displacement of the lower polar crossing vessels causing the UPJO Receives: Procedure: pyeloplasty |
| Dismembered pyeloplasty | Active comparator | classic Anderson-Hynes procedure Receives: Procedure: pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the two techniques regarding the success rate
both techniques are supposed to have similar results
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized intervention study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Rammah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895422
- Sponsor's protocol ID
- MD-85-2023
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the researchers would determine whether they would share or not during the study
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Laparoscopic and Robot Assisted Management of Uretero-pelvic Junction Obstruction Disease Caused by Crossing Vessels for Adult Patients
- ClinicalTrials.gov ID
- NCT05895422
- Acronym / sponsor ID
- MD-85-2023
- Conditions
- Ureteropelvic Junction Obstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Jun 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.
an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.
Detailed description
in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized intervention study
| Arm | Type | Receives |
|---|---|---|
| vascular hitch | Experimental | Procedure: pyeloplastydisplacement of the lower polar crossing vessels causing the UPJO |
| Dismembered pyeloplasty | Active comparator | Procedure: pyeloplastyclassic Anderson-Hynes procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients with UPJO above 18 years
- UPJO caused by crossing vessels confirmed by CT angiography
- Symptomatic UPJO
Key exclusion criteria (3 listed)
- recurrent UPJO after a previous trial of open repair ,
- secondary UPJO after open renal surgery.
- UPJO in non functioning kidney
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 |
|---|---|---|
| pyeloplastyrepair of the uPJO | Procedure or surgery | Dismembered pyeloplasty, vascular hitch |
Primary outcome
comparing the two techniques regarding the success rate
Time frame: 2 years
both techniques are supposed to have similar results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: Undecided. the researchers would determine whether they would share or not during the study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pyeloplasty in people with Ureteropelvic Junction Obstruction, run by Cairo University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed M Rammah, MD (2001005622939, ahmedrammah2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the two techniques regarding the success rate (time frame: 2 years). 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 9 Jun 2023.