Breast DiseasesNCT04911101
Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
A study testing Excision with 7G needle and Excision with 10G needle in people with Breast Diseases, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Excision with 7G needle and Excision with 10G needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 19 Nov 2019to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-verified probably benign breast lesion less than 20 mm size
- Biopsy-verified benign breast lesion less than 30 mm size
- Screen-detected group of microcalcifications under 10 mm size
Who cannot join
- Age less than 18 years of age
- Inability to understand the meaning of informed consent
- Pregnancy
- Breast-feeding
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17164
Athanasios Zouzos, MD, +46851770000, athanasios.zouzos@sll.se
Fredrik Strand, MD PhD
About this study
The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.
- Conditions
- Breast Diseases
- Being tested
- Excision with 7G needle, Excision with 10G needle
- Keywords
- Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision with 7G needleDevice
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Excision with 10G needleDevice
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
| Study group | Role | What they receive |
|---|---|---|
| 7G needle | Experimental | 7G needle dimension used Receives: Device: Excision with 7G needle |
| 10G needle | Experimental | 10G needle dimension used Receives: Device: Excision with 10G needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excision time
Time from excision start to excision stop - reported by radiologist
Measured: Baseline
Pain assessed by NRS 2 weeks after baseline
Patient pain level during the experience - reported by patient in a 10-level NRS
Measured: 2 weeks after baseline
Secondary outcomes (7)
Number of patients with bleeding despite 10 minutes compression
Bleeding despite 10 minutes compression - reported by radiologist
Measured: Baseline
Radicality assessment fractions
Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist
Measured: Baseline
Self-reported number of patients who would recommend the procedure to others
Would the patient recommend the same procedure to others in same situation - reported by patient as yes or no
Measured: 1 week after baseline
Self-reported satisfaction with cosmetic result assessed by a categorical scale
How dissatisfied is the patient with the cosmetic result - reported by patient - using a categorical scale from "not at all", "somewhat", "rather", "very".
Measured: 1 week after baseline
Number of patients with self-reported occurrence of wound infection
Occurrence of wound infection - reported by patient as yes or no
Measured: 1 week after baseline
Remaining scar
Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection
Measured: 6 months after baseline
Pain assessed by NRS at baseline
Patient pain level during procedure - reported by patient in a 10-level NRS
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start19 Nov 2019
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by Karolinska University 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital, St Goran's Hospital, Uppsala University Hospital
- Responsible party
- Principal investigator, Fredrik Strand, Karolinska University Hospital
- Investigators
- Fredrik Strand, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911101
- Sponsor's protocol ID
- K2019-7986
- Status last verified
- Mar 2023
- First submitted
- 20 May 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
- ClinicalTrials.gov ID
- NCT04911101
- Acronym / sponsor ID
- K2019-7986
- Conditions
- Breast Diseases
- Keywords
- Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital, St Goran's Hospital, Uppsala University Hospital
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 2 Jun 2021 (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 purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7G needle | Experimental | Device: Excision with 7G needle7G needle dimension used |
| 10G needle | Experimental | Device: Excision with 10G needle10G needle dimension used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-verified probably benign breast lesion less than 20 mm size
- Biopsy-verified benign breast lesion less than 30 mm size
- Screen-detected group of microcalcifications under 10 mm size
Key exclusion criteria (4 listed)
- Age less than 18 years of age
- Inability to understand the meaning of informed consent
- Pregnancy
- Breast-feeding
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 |
|---|---|---|
| Excision with 7G needleVacuum-assisted excision using a biopsy needle with two alternative dimensions | Device | 7G needle |
| Excision with 10G needleVacuum-assisted excision using a biopsy needle with two alternative dimensions | Device | 10G needle |
Primary outcome
Excision time
Time frame: Baseline
Time from excision start to excision stop - reported by radiologist
Pain assessed by NRS 2 weeks after baseline
Time frame: 2 weeks after baseline
Patient pain level during the experience - reported by patient in a 10-level NRS
7 secondary outcomes
Number of patients with bleeding despite 10 minutes compression
Time frame: Baseline
Radicality assessment fractions
Time frame: Baseline
Self-reported number of patients who would recommend the procedure to others
Time frame: 1 week after baseline
Self-reported satisfaction with cosmetic result assessed by a categorical scale
Time frame: 1 week after baseline
Number of patients with self-reported occurrence of wound infection
Time frame: 1 week after baseline
Remaining scar
Time frame: 6 months after baseline
Pain assessed by NRS at baseline
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- 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.
Fredrik Strand, MD PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision with 7G needle and Excision with 10G needle in people with Breast Diseases, run by Karolinska University Hospital at 1 site in Sweden.
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 4 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 8 Mar 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Strand, MD PhD (+46851770000, fredrik.strand@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excision time (time frame: Baseline). 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 Mar 2023.