Trial Outcomes & Findings for Patient Controlled Tissue Expansion for Breast Reconstruction (NCT NCT01425268)

Last Updated: 2017-06-27

Results Overview

The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

12 months

Results posted on

2017-06-27

Participant Flow

Participants were recruited were current patients at the investigator's practice who were scheduled to undergo two-stage breast reconstruction between November 2011 - December 2014.

Participant milestones

Participant milestones
Measure	AeroForm Tissue Expansion AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Overall Study STARTED	106	52
Overall Study COMPLETED	98	52
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AeroForm Tissue Expansion AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Overall Study Withdrawal by Subject	2	0
Overall Study Sponsor Decision	5	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Patient Controlled Tissue Expansion for Breast Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AeroForm Tissue Expansion n=98 Participants AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion n=52 Participants Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	49 Participants n=7 Participants	141 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 9.83 • n=5 Participants	51.1 years STANDARD_DEVIATION 9.88 • n=7 Participants	49.7 years STANDARD_DEVIATION 9.87 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	52 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	52 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.

Outcome measures

Outcome measures
Measure	AeroForm Tissue Expansion n=155 Breasts AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion n=83 Breasts Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event	149 Breasts	82 Breasts

SECONDARY outcome

Timeframe: 12 months

Population: All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)

The median number of days taken to complete the expansion process.

Outcome measures

Outcome measures
Measure	AeroForm Tissue Expansion n=142 breasts AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion n=82 breasts Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Expansion Days	21 days Interval 6.0 to 169.0	46 days Interval 5.0 to 280.0

Adverse Events

AeroForm Tissue Expansion

Serious events: 21 serious events

Other events: 46 other events

Deaths: 0 deaths

Saline Tissue Expansion

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	AeroForm Tissue Expansion n=99 participants at risk AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion n=52 participants at risk Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
General disorders Pain	10.1% 10/99 • Number of events 10 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	19.2% 10/52 • Number of events 10 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Delayed Wound Healing	14.1% 14/99 • Number of events 14 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	5.8% 3/52 • Number of events 3 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Seroma	14.1% 14/99 • Number of events 14 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	9.6% 5/52 • Number of events 5 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Infections and infestations Infection	8.1% 8/99 • Number of events 8 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	7.7% 4/52 • Number of events 4 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.

Additional Information

Director of Clinical Affairs

AirXpanders

Phone: 650-390-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AeroForm Tissue Expansion n=99 participants at risk AeroForm Tissue Expansion inflation with carbon dioxide by remote control AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.	Saline Tissue Expansion n=52 participants at risk Saline Tissue Expansion inflated by needle injections of saline Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Injury, poisoning and procedural complications Hematoma, Breast	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	1.9% 1/52 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Nervous system disorders Stroke, Mild	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Blood and lymphatic system disorders Neutropenic Fever	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Seroma	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Skin and subcutaneous tissue disorders Red Breast Syndrome	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
General disorders Extrusion	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	1.9% 1/52 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Hematoma, Chest VAP Site	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Infections and infestations Cellulitis	5.1% 5/99 • Number of events 6 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	3.8% 2/52 • Number of events 2 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Infections and infestations Wound Infection	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	3.8% 2/52 • Number of events 2 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Delayed Wound Healing	2.0% 2/99 • Number of events 2 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	1.9% 1/52 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Wound Dehiscence	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Erosion	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
General disorders Deflation	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	1.9% 1/52 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
General disorders Under-Expansion	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Product Issues Over-Expansion	4.0% 4/99 • Number of events 5 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
General disorders Exposure	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.
Injury, poisoning and procedural complications Muscle Disruption	1.0% 1/99 • Number of events 1 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.	0.00% 0/52 • 1 year All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99). AEs assessed by investigators for severity, seriousness and relationship to device or procedure. AEs coded to MedDRA standardized terms.