Breast BiopsyNCT03212040
14 g vs. 16 g in Breast Biopsy
A study testing needle biopsy in people with Breast Biopsy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Biopsy
- What is being tested?
- needle biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- 5 Dec 2011to 7 Jun 2018
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years
- Informed consent available
- Palpable and non-palpable breast findings
- Tumor size 5-20 mm
- Findings of sonographic BI-RADS® classification 2-5.
- Guideline-oriented indication for bioptic clarification
Who cannot join
- No reliable sonographic demarcation of the finding
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
- Conditions
- Breast Biopsy
- Being tested
- needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle biopsyDiagnostic test
breast biopsy using different needle gauges
| Study group | Role | What they receive |
|---|---|---|
| 14 gauge needle biopsy | Active comparator | breast biopsy will be performed with 14 gauge needle Receives: Diagnostic Test: needle biopsy |
| 16 gauge needle biopsy | Active comparator | breast biopsy will be performed with 16 gauge needle Receives: Diagnostic Test: needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
- Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen
- Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy
- Additive diagnostic accuracy to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Measured: 1 year
Diagnostic quality
- Diagnostic quality of specimen to achieve an accurate histological diagnosis
- Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy
- Additive diagnostic quality to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Measured: 1 year
Secondary outcomes (2)
Pain related to the biopsy procedure
Subjective pain perception measured visual analog scale
Measured: 1 year
Duration time of the biopsy procedure
Duration time of the biopsy procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start5 Dec 2011
- Primary completion18 Feb 2013
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast BiopsyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of 14 vs 16 gauge needles
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212040
- Sponsor's protocol ID
- Gauge 14/16
- Status last verified
- Feb 2019
- First submitted
- 27 Jun 2017
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
- ClinicalTrials.gov ID
- NCT03212040
- Acronym / sponsor ID
- Gauge 14/16
- Conditions
- Breast Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 18 Feb 2013 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 11 Jul 2017 (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.
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of 14 vs 16 gauge needles
| Arm | Type | Receives |
|---|---|---|
| 14 gauge needle biopsy | Active comparator | Diagnostic Test: needle biopsybreast biopsy will be performed with 14 gauge needle |
| 16 gauge needle biopsy | Active comparator | Diagnostic Test: needle biopsybreast biopsy will be performed with 16 gauge needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age of 18 years
- Informed consent available
- Palpable and non-palpable breast findings
- Tumor size 5-20 mm
- Findings of sonographic BI-RADS® classification 2-5.
Key exclusion criteria (2 listed)
- No reliable sonographic demarcation of the finding
- Pregnancy
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 |
|---|---|---|
| needle biopsybreast biopsy using different needle gauges | Diagnostic test | 14 gauge needle biopsy, 16 gauge needle biopsy |
Primary outcome
Diagnostic accuracy
Time frame: 1 year
* Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen * Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy * Additive diagnostic accuracy to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Diagnostic quality
Time frame: 1 year
* Diagnostic quality of specimen to achieve an accurate histological diagnosis * Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy * Additive diagnostic quality to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
2 secondary outcomes
Pain related to the biopsy procedure
Time frame: 1 year
Duration time of the biopsy procedure
Time frame: 1 year
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 22 Jul 2024.
- 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 needle biopsy in people with Breast Biopsy, run by University Hospital Tuebingen at 1 site in Germany.
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 6 inclusion and 2 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 22 Jul 2024. 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 Germany. 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?
Diagnostic accuracy (time frame: 1 year). 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 22 Jul 2024.