Benign Prostate Hypertrophy(BPH)NCT07251621
Evaluation of the Application Effect of a Surgical Navigation System in HoLEP Surgery
A study testing use the 3D imaging-assisted surgical navigation system during surgery in people with Benign Prostate Hypertrophy(BPH), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
3D imaging-assisted surgical navigation system was established using the following specific procedures: 1) Prostate MRI Acquisition and 3D Reconstruction: patient prostate MRI images are acquired, and professional engineers complete 3D reconstruction; 2) Data Import to Diagnostic Ultrasound System: Reconstructed… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- use the 3D imaging-assisted surgical navigation system during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2024
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) Clinically diagnosed BPH patients with LUTS; 2) Voluntarily participated in the clinical trial and provided written informed consent; 3) Met the surgical intervention indications outlined in the 2019 'Chinese Guidelines for Diagnosis and Treatment of Urological Diseases'; 4) Completed preoperative BPH evaluations, including International Prostate Symptom Score (IPSS) and Quality of Life (QoL) assessment.
Who cannot join
- 1) Refusal to participate in the clinical trial; 2) Presence of severe uncontrolled medical conditions or psychiatric disorders; 3) Cognitive impairment impeding normal communication.
Trial locations and contacts
1 site in 1 country.
About this study
3D imaging-assisted surgical navigation system was established using the following specific procedures: 1) Prostate MRI Acquisition and 3D Reconstruction: patient prostate MRI images are acquired, and professional engineers complete 3D reconstruction; 2) Data Import to Diagnostic Ultrasound System: Reconstructed prostate MRI images and P-3DRI (Prostate 3D Reconstruction Image) data are imported into the Diagnostic Ultrasound system; 3) Transrectal Ultrasound Probe Placement: The transrectal ultrasound probe is secured to a dedicated holder. The probe is inserted into the patient's rectum to locate the prostate. After manual adjustment to optimize imaging, the holder is fixed in position; 4) Initial Position Registration: The Diagnostic Ultrasound system integrates prostate MRI, P-3DRI, and real-time ultrasound images. Spatial correspondence between P-3DRI and the actual prostate position is established using real-time ultrasound; 5) Cystoscope-Electromagnetic Navigation Assembly: A self-designed electromagnetic navigation connector links the electromagnetic sensor to the cystoscope. The ultrasound probe is simultaneously equipped with an electromagnetic sensor; 6) Real-time Spatial Tracking and Fusion: The electromagnetic navigation module tracks spatial positions of surgical instruments and the ultrasound probe. These positions are fused with real-time ultrasound coordinates.
Through the above steps, the relative position between surgical instruments and the prostate is displayed in real time, achieving intraoperative navigation. All procedures were performed by the same Associate Chief Physician at our medical center. Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- use the 3D imaging-assisted surgical navigation system during surgery
- Keywords
- Benign Prostate Hypertrophy, holmium laser enucleation of the prostate, Surgical Navigation System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use the 3D imaging-assisted surgical navigation system during surgeryProcedure or surgery
Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.
| Study group | Role | What they receive |
|---|---|---|
| use of the 3D imaging-assisted surgical navigation system during surgery | Experimental | Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group Receives: Procedure: use the 3D imaging-assisted surgical navigation system during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Urinary Incontinence (Defined as an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score ≥ 1), Urethral Stricture (Defined as recurrence of dysuria or narrowed urine stream postoperatively, confirmed by cystoscopy)
Measured: month 1；month 3；
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Apr 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251621
- Sponsor's protocol ID
- S202403101
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Application Effect of a Surgical Navigation System in HoLEP Surgery
- ClinicalTrials.gov ID
- NCT07251621
- Acronym / sponsor ID
- S202403101
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Keywords
- Benign Prostate Hypertrophy, holmium laser enucleation of the prostate, Surgical Navigation System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Nov 2025 (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.
3D imaging-assisted surgical navigation system was established using the following specific procedures: 1) Prostate MRI Acquisition and 3D Reconstruction: patient prostate MRI images are acquired, and professional engineers complete 3D reconstruction; 2) Data Import to Diagnostic Ultrasound System: Reconstructed prostate MRI images and P-3DRI (Prostate 3D Reconstruction Image) data are imported into the Diagnostic Ultrasound system; 3) Transrectal Ultrasound Probe Placement: The transrectal ultrasound probe is secured to a dedicated holder. The probe is inserted into the patient's rectum to locate the prostate. After manual adjustment to optimize imaging, the holder is fixed in position; 4) Initial Position Registration: The Diagnostic Ultrasound system integrates prostate MRI, P-3DRI, and real-time ultrasound images. Spatial correspondence between P-3DRI and the actual prostate position is established using real-time ultrasound; 5) Cystoscope-Electromagnetic Navigation Assembly: A self-designed electromagnetic navigation connector links the electromagnetic sensor to the cystoscope. The ultrasound probe is simultaneously equipped with an electromagnetic sensor; 6) Real-time Spatial Tracking and Fusion: The electromagnetic navigation module tracks spatial positions of surgical instruments and the ultrasound probe. These positions are fused with real-time ultrasound coordinates.
Through the above steps, the relative position between surgical instruments and the prostate is displayed in real time, achieving intraoperative navigation. All procedures were performed by the same Associate Chief Physician at our medical center. Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| use of the 3D imaging-assisted surgical navigation system during surgery | Experimental | Procedure: use the 3D imaging-assisted surgical navigation system during surgeryBased on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Clinically diagnosed BPH patients with LUTS; 2) Voluntarily participated in the clinical trial and provided written informed consent; 3) Met the surgical intervention indications outlined in the 2019 'Chinese Guidelines for Diagnosis and Treatment of Urological Diseases'; 4) Completed preoperative BPH evaluations, including International Prostate Symptom Score (IPSS) and Quality of Life (QoL) assessment.
Key exclusion criteria (1 listed)
- 1) Refusal to participate in the clinical trial; 2) Presence of severe uncontrolled medical conditions or psychiatric disorders; 3) Cognitive impairment impeding normal communication.
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 |
|---|---|---|
| use the 3D imaging-assisted surgical navigation system during surgeryBased on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group. | Procedure or surgery | use of the 3D imaging-assisted surgical navigation system during surgery |
Primary outcome
postoperative complications
Time frame: month 1；month 3；
Urinary Incontinence (Defined as an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score ≥ 1), Urethral Stricture (Defined as recurrence of dysuria or narrowed urine stream postoperatively, confirmed by cystoscopy)
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 26 Nov 2025.
- 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?
A study testing use the 3D imaging-assisted surgical navigation system during surgery in people with Benign Prostate Hypertrophy(BPH), run by Chinese PLA General Hospital 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 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: finished, as of the sponsor's last update on 26 Nov 2025. 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.
What does the primary outcome measure?
postoperative complications (time frame: month 1；month 3；). 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 26 Nov 2025.