Trial Outcomes & Findings for MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery (NCT NCT00749931)

NCT ID: NCT00749931

Last Updated: 2014-06-27

Results Overview

Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 664 participants
• Primary outcome timeframe: two weeks after surgery
• Results posted on: 2014-06-27

Participant Flow

Participant milestones

Measure	Standard of Care (SOC) Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure	Device + (Standard of Care) SOC Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure	Roll-in Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure
Overall Study STARTED	298	298	68
Overall Study COMPLETED	298	298	68
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Baseline characteristics by cohort

Measure	Standard of Care (SOC) n=298 Participants Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure	Device + (Standard of Care) SOC n=298 Participants Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure	Total n=596 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 11.1 • n=5 Participants	60.3 years STANDARD_DEVIATION 11.4 • n=7 Participants	60.3 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	298 Participants n=5 Participants	298 Participants n=7 Participants	596 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: two weeks after surgery

Population: The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen ("PSS" - Positive specimen subjects)

Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

Outcome measures

Measure	Standard of Care (SOC) n=147 Participants Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure	Device + (Standard of Care) SOC n=163 Participants Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.	22.4 percentage of participants analyzed	71.8 percentage of participants analyzed

POST_HOC outcome

Timeframe: Up to 2 months post-surgery

Outcome measures

Measure	Standard of Care (SOC) n=298 Participants Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure	Device + (Standard of Care) SOC n=298 Participants Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure
Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens	20.8 percentage of participants	10.0 percentage of participants

Adverse Events

Standard of Care (SOC)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Device + (Standard of Care) SOC

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Roll-in

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care (SOC) n=298 participants at risk Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure	Device + (Standard of Care) SOC n=298 participants at risk Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure	Roll-in n=68 participants at risk Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure
Infections and infestations Infections and infestations	0.34% 1/298 • Number of events 1 • Up to 2 months post-surgery.	0.67% 2/298 • Number of events 2 • Up to 2 months post-surgery.	2.9% 2/68 • Number of events 2 • Up to 2 months post-surgery.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.0% 3/298 • Number of events 3 • Up to 2 months post-surgery.	0.67% 2/298 • Number of events 2 • Up to 2 months post-surgery.	0.00% 0/68 • Up to 2 months post-surgery.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/298 • Up to 2 months post-surgery.	0.34% 1/298 • Number of events 1 • Up to 2 months post-surgery.	0.00% 0/68 • Up to 2 months post-surgery.
Reproductive system and breast disorders Reproductive system and breast disorders	0.34% 1/298 • Number of events 1 • Up to 2 months post-surgery.	0.00% 0/298 • Up to 2 months post-surgery.	0.00% 0/68 • Up to 2 months post-surgery.
Vascular disorders Vascular disorders	0.00% 0/298 • Up to 2 months post-surgery.	0.34% 1/298 • Number of events 1 • Up to 2 months post-surgery.	1.5% 1/68 • Number of events 1 • Up to 2 months post-surgery.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Manager

Dune Medical Devices

Phone: +97246178000

Email: shiri@dunemedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place