Autosomal Dominant Polycystic Kidney Disease (ADPKD)ADPKDR-ONCT07355114
Robotic vs Open Nephrectomy for ADPKD
An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by University of Bologna at 1 site in Italy.
Trial summary
The goal of this observational prospective cohort study is to evaluate the feasibility, safety, and postoperative outcomes of robotic-assisted unilateral native nephrectomy using the Medtronic Hugo™ RAS system compared with the open surgical approach in patients with autosomal dominant polycystic kidney disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult Patients who underwent unilateral nephrectomy for ADPKD (Robotic with HUGO RAS System or open)
Who may be able to join
- Adult Patients who underwent unilateral nephrectomy for ADPKD
Who cannot join
- Patients who underwent bilateral nephrectomy for ADPKD were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCSS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bo, 40138
About this study
Official title: Robotic-assisted Unilateral Nephrectomy for Autosomal Dominant Polycystic Kidney
The goal of this observational prospective cohort study is to evaluate the feasibility, safety, and postoperative outcomes of robotic-assisted unilateral native nephrectomy using the Medtronic Hugo™ RAS system compared with the open surgical approach in patients with autosomal dominant polycystic kidney disease (ADPKD)
The main question(s) it aims to answer are:
Read more
Is robotic-assisted unilateral nephrectomy with the Hugo™ RAS system feasible and safe in patients with ADPKD? Does robotic-assisted nephrectomy provide comparable or improved postoperative outcomes (e.g., complications, transfusion rates, length of hospital stay) compared with open nephrectomy? Researchers will compare robotic-assisted unilateral nephrectomy (Hugo™ RAS) with open unilateral nephrectomy to see if the robotic approach results in similar morbidity with shorter hospital stay, despite longer operative times.
Participants are adult patients with ADPKD undergoing unilateral native nephrectomy at a single tertiary transplant center, most of whom have end-stage renal disease and are candidates for or recipients of kidney transplantation. Both male and female patients were included; patients undergoing bilateral nephrectomy were excluded.
- Keywords
- ADPKD
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open nephrectomy | Unilateral Nephrectomy for ADPKD | |
| Robotic Nephrectomy | Unilateral Robotic nephrectomy for ADPKD with Hugo RAS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality by 90 day
Mortality by 90 day
Measured: By 90 days
Secondary outcomes (1)
Postoperative complications
Postoperative complications described by Clavien-Dindo Classification
Measured: By 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2023
- Primary completion30 Aug 2025
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Principal investigator, Matteo Ravaioli, Professor, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355114
- Sponsor's protocol ID
- ADPKDR-O
- Acronym
- ADPKDR-O
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Unilateral Nephrectomy for Autosomal Dominant Polycystic Kidney
- ClinicalTrials.gov ID
- NCT07355114
- Acronym / sponsor ID
- ADPKDR-O / ADPKDR-O
- Keywords
- ADPKD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Jan 2026 (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 goal of this observational prospective cohort study is to evaluate the feasibility, safety, and postoperative outcomes of robotic-assisted unilateral native nephrectomy using the Medtronic Hugo™ RAS system compared with the open surgical approach in patients with autosomal dominant polycystic kidney disease (ADPKD)
The main question(s) it aims to answer are:
Is robotic-assisted unilateral nephrectomy with the Hugo™ RAS system feasible and safe in patients with ADPKD? Does robotic-assisted nephrectomy provide comparable or improved postoperative outcomes (e.g., complications, transfusion rates, length of hospital stay) compared with open nephrectomy? Researchers will compare robotic-assisted unilateral nephrectomy (Hugo™ RAS) with open unilateral nephrectomy to see if the robotic approach results in similar morbidity with shorter hospital stay, despite longer operative times.
Participants are adult patients with ADPKD undergoing unilateral native nephrectomy at a single tertiary transplant center, most of whom have end-stage renal disease and are candidates for or recipients of kidney transplantation. Both male and female patients were included; patients undergoing bilateral nephrectomy were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open nephrectomy | – | –Unilateral Nephrectomy for ADPKD |
| Robotic Nephrectomy | – | –Unilateral Robotic nephrectomy for ADPKD with Hugo RAS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients who underwent unilateral nephrectomy for ADPKD (Robotic with HUGO RAS System or open)
Key inclusion criteria (1 listed)
- Adult Patients who underwent unilateral nephrectomy for ADPKD
Key exclusion criteria (1 listed)
- Patients who underwent bilateral nephrectomy for ADPKD were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality by 90 day
Time frame: By 90 days
Mortality by 90 day
1 secondary outcome
Postoperative complications
Time frame: By 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by University of Bologna at 1 site in Italy.
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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality by 90 day (time frame: By 90 days). 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 21 Jan 2026.