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Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

Primary Purpose

Breast Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Excision with 7G needle
Excision with 10G needle
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Diseases focused on measuring Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age less than 18 years of age
  • Inability to understand the meaning of informed consent
  • Pregnancy
  • Breast-feeding

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

7G needle

10G needle

Arm Description

7G needle dimension used

10G needle dimension used

Outcomes

Primary Outcome Measures

Excision time
Time from excision start to excision stop - reported by radiologist
Pain assessed by NRS 2 weeks after baseline
Patient pain level during the experience - reported by patient in a 10-level NRS

Secondary Outcome Measures

Number of patients with bleeding despite 10 minutes compression
Bleeding despite 10 minutes compression - reported by radiologist
Radicality assessment fractions
Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist
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
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".
Number of patients with self-reported occurrence of wound infection
Occurrence of wound infection - reported by patient as yes or no
Remaining scar
Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection
Pain assessed by NRS at baseline
Patient pain level during procedure - reported by patient in a 10-level NRS

Full Information

First Posted
May 20, 2021
Last Updated
March 7, 2023
Sponsor
Karolinska University Hospital
Collaborators
Stockholm South General Hospital, Capio Sankt Görans Hospital, Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04911101
Brief Title
Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
Official Title
Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Stockholm South General Hospital, Capio Sankt Görans Hospital, Uppsala University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
7G needle
Arm Type
Experimental
Arm Description
7G needle dimension used
Arm Title
10G needle
Arm Type
Experimental
Arm Description
10G needle dimension used
Intervention Type
Device
Intervention Name(s)
Excision with 7G needle
Intervention Description
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Intervention Type
Device
Intervention Name(s)
Excision with 10G needle
Intervention Description
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Primary Outcome Measure Information:
Title
Excision time
Description
Time from excision start to excision stop - reported by radiologist
Time Frame
Baseline
Title
Pain assessed by NRS 2 weeks after baseline
Description
Patient pain level during the experience - reported by patient in a 10-level NRS
Time Frame
2 weeks after baseline
Secondary Outcome Measure Information:
Title
Number of patients with bleeding despite 10 minutes compression
Description
Bleeding despite 10 minutes compression - reported by radiologist
Time Frame
Baseline
Title
Radicality assessment fractions
Description
Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist
Time Frame
Baseline
Title
Self-reported number of patients who would recommend the procedure to others
Description
Would the patient recommend the same procedure to others in same situation - reported by patient as yes or no
Time Frame
1 week after baseline
Title
Self-reported satisfaction with cosmetic result assessed by a categorical scale
Description
How dissatisfied is the patient with the cosmetic result - reported by patient - using a categorical scale from "not at all", "somewhat", "rather", "very".
Time Frame
1 week after baseline
Title
Number of patients with self-reported occurrence of wound infection
Description
Occurrence of wound infection - reported by patient as yes or no
Time Frame
1 week after baseline
Title
Remaining scar
Description
Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection
Time Frame
6 months after baseline
Title
Pain assessed by NRS at baseline
Description
Patient pain level during procedure - reported by patient in a 10-level NRS
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Age less than 18 years of age Inability to understand the meaning of informed consent Pregnancy Breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Strand, MD PhD
Phone
+46851770000
Email
fredrik.strand@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Zouzos, MD
Phone
+46851770000
Email
athanasios.zouzos@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Strand, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17164
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Zouzos, MD
Phone
+46851770000
Email
athanasios.zouzos@sll.se
First Name & Middle Initial & Last Name & Degree
Fredrik Strand, MD PhD
First Name & Middle Initial & Last Name & Degree
Athanasios Zouzos, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

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