BiopsyPhase 2NCT07800013
Full Core Biopsy Needle vs Side Notch Biopsy Needle
A Phase 2 study testing Merit Medical CorVocet full-core disposable biopsy needle and Bard Side notch disposable biopsy needle in people with Biopsy, run by West China Hospital at 1 site in China.
Trial summary
Compare the quality of samples collected by the new fully automatic full-core biopsy needle with that of existing biopsy needles, including length, weight, and debris rate Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biopsy
- What is being tested?
- Merit Medical CorVocet full-core disposable biopsy needle and Bard Side notch disposable biopsy needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Mar 2026
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old
- Imaging suggests deep organ space-occupying lesion, requiring biopsy to confirm its nature
- Coagulation function is basically normal (INR≤1.5)
- Lesion short diameter ≥4cm
- Signed informed consent form.
Who cannot join
- Patients with coagulopathy who have not discontinued anticoagulant therapy
- Patients with severe infections or pregnancy
- Patients who, in the investigator's judgment, are not suitable for enrollment or have a high risk of puncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specimen Quality and Safety of Full-core vs. Side-notch Disposable Biopsy Needles in CT-guided Percutaneous Biopsy: a Single-center Randomized Controlled Study
Compare the quality of samples collected by the new fully automatic full-core biopsy needle with that of existing biopsy needles, including length, weight, and debris rate
- Conditions
- Biopsy
- Being tested
- Merit Medical CorVocet full-core disposable biopsy needle, Bard Side notch disposable biopsy needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merit Medical CorVocet full-core disposable biopsy needleDevice
Merit Medical CorVocet full-core disposable biopsy needle
Bard Side notch disposable biopsy needleDevice
Bard Side notch disposable biopsy needle
| Study group | Role | What they receive |
|---|---|---|
| Full Core | Experimental | Not described Receives: Device: Merit Medical CorVocet full-core disposable biopsy needle |
| Side Notch | Active comparator | Not described Receives: Device: Bard Side notch disposable biopsy needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of specimen
Length of specimen after biopsy, mm
Measured: From enrollment to the end of biopsy at 1 week
Mass
Mass of specimen after biopsy, mg
Measured: From enrollment to the end of biopsy at 1 week
Secondary outcomes (2)
Fragmentation
The grading of biopsy tissue fragmentation ranges from grade 1 to grade 5, with higher grades indicating more intact tissue
Measured: From enrollment to the end of biopsy at 1 week
Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy
Incidence of biopsy-related adverse events (AEs) occurring within 7 days post-procedure, including but not limited to bleeding, pneumothorax, infection, and pain. AEs will be graded according to CTCAE v5.0.
Measured: From enrollment to the end of biopsy at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Jul 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiopsyStudies of the same condition, open and under way.
- More trials run by West China 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai Tao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800013
- Sponsor's protocol ID
- 2025（94）
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Quality and Safety of Full-core vs. Side-notch Disposable Biopsy Needles in CT-guided Percutaneous Biopsy: a Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07800013
- Acronym / sponsor ID
- 2025（94）
- Conditions
- Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 2 Sep 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.
Compare the quality of samples collected by the new fully automatic full-core biopsy needle with that of existing biopsy needles, including length, weight, and debris rate
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Core | Experimental | Device: Merit Medical CorVocet full-core disposable biopsy needle |
| Side Notch | Active comparator | Device: Bard Side notch disposable biopsy needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-80 years old
- Imaging suggests deep organ space-occupying lesion, requiring biopsy to confirm its nature
- Coagulation function is basically normal (INR≤1.5)
- Lesion short diameter ≥4cm
- Signed informed consent form.
Key exclusion criteria (3 listed)
- Patients with coagulopathy who have not discontinued anticoagulant therapy
- Patients with severe infections or pregnancy
- Patients who, in the investigator's judgment, are not suitable for enrollment or have a high risk of puncture.
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 |
|---|---|---|
| Merit Medical CorVocet full-core disposable biopsy needleMerit Medical CorVocet full-core disposable biopsy needle | Device | Full Core |
| Bard Side notch disposable biopsy needleBard Side notch disposable biopsy needle | Device | Side Notch |
Primary outcome
Length of specimen
Time frame: From enrollment to the end of biopsy at 1 week
Length of specimen after biopsy, mm
Mass
Time frame: From enrollment to the end of biopsy at 1 week
Mass of specimen after biopsy, mg
2 secondary outcomes
Fragmentation
Time frame: From enrollment to the end of biopsy at 1 week
Incidence of Procedure-Related Adverse Events Within 7 Days Post-Biopsy
Time frame: From enrollment to the end of biopsy at 1 week
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 8 Sep 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?
A Phase 2 study testing Merit Medical CorVocet full-core disposable biopsy needle and Bard Side notch disposable biopsy needle in people with Biopsy, run by West China 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 5 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: finished, as of the sponsor's last update on 8 Sep 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of specimen (time frame: From enrollment to the end of biopsy at 1 week). The study lists 2 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 8 Sep 2026.