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

NCT04911101 | Unknown FDA Device

• 1 other identifier: K2019-7986
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Diseases

Keywords

Vacuum-assisted excision; Breast; Minimally invasive procedure; Needle size

Outcome Measures

Primary Outcomes (2)

• Excision time

  Time from excision start to excision stop - reported by radiologist

  Baseline

• Pain assessed by NRS 2 weeks after baseline

  Patient pain level during the experience - reported by patient in a 10-level NRS

  2 weeks after baseline

Secondary Outcomes (7)

• Number of patients with bleeding despite 10 minutes compression

  Baseline

• Radicality assessment fractions

  Baseline

• Self-reported number of patients who would recommend the procedure to others

  1 week after baseline

• Self-reported satisfaction with cosmetic result assessed by a categorical scale

  1 week after baseline

• Number of patients with self-reported occurrence of wound infection

  1 week after baseline

Study Arms (2)

7G needle

EXPERIMENTAL

7G needle dimension used

Device: Excision with 7G needle

10G needle

EXPERIMENTAL

10G needle dimension used

Device: Excision with 10G needle

Interventions

Excision with 7G needle DEVICE

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

7G needle

Excision with 10G needle DEVICE

Vacuum-assisted excision using a biopsy needle with two alternative dimensions

10G needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Stockholm South General Hospital: collaborator
• Capio Sankt Görans Hospital: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17164, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Diseases

Interventions

Needles

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Fredrik Strand, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Strand, MD PhD

CONTACT

+46851770000; fredrik.strand@sll.se

Athanasios Zouzos, MD

CONTACT

+46851770000; athanasios.zouzos@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant (biträdande överläkare)

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: November 19, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)