Trial Outcomes & Findings for PRIMO Post-Market Clinical Follow Up Study (NCT NCT04843436)

NCT ID: NCT04843436

Last Updated: 2026-06-09

Results Overview

Ability to complete the surgical task with Symani as intended by the surgeon

Recruitment status

COMPLETED

Study phase

Target enrollment

427 participants

Primary outcome timeframe

Duration of the robotic anastomotic portion of the participants index procedure

Results posted on

2026-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic Assisted Microsurgery Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery
Overall Study STARTED	427
Overall Study Free Flap	274
Overall Study LVA	129
Overall Study Replantation	12
Overall Study COMPLETED	412
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data only collected for 426 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic Assisted Microsurgery n=427 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery
Age, Continuous	53.8 years STANDARD_DEVIATION 13.39 • n=426 Participants • Age data only collected for 426 participants.
Sex: Female, Male Female	279 Participants n=426 Participants • Sex Data only reported for 426 patients
Sex: Female, Male Male	147 Participants n=426 Participants • Sex Data only reported for 426 patients
Race/Ethnicity, Customized Caucasian	400 Participants n=421 Participants • Ethnicity Data only reported for 421 patients
Race/Ethnicity, Customized Black	10 Participants n=421 Participants • Ethnicity Data only reported for 421 patients
Race/Ethnicity, Customized Asian	5 Participants n=421 Participants • Ethnicity Data only reported for 421 patients
Race/Ethnicity, Customized Other	6 Participants n=421 Participants • Ethnicity Data only reported for 421 patients
Region of Enrollment Austria	6 participants n=427 Participants
Region of Enrollment Belgium	73 participants n=427 Participants
Region of Enrollment Finland	26 participants n=427 Participants
Region of Enrollment Italy	43 participants n=427 Participants
Region of Enrollment Switzerland	5 participants n=427 Participants
Region of Enrollment Germany	191 participants n=427 Participants
Region of Enrollment Spain	83 participants n=427 Participants

PRIMARY outcome

Timeframe: Duration of the robotic anastomotic portion of the participants index procedure

Population: This effectiveness endpoint is assessed for all robotic procedures undertaken on patients in the FAS

Ability to complete the surgical task with Symani as intended by the surgeon

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=626 anastomoses Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Procedure Robotic Success	94.7 percentage of successful anastomoses Interval 92.7 to 96.3	—	—

SECONDARY outcome

Timeframe: Procedure

Population: robotic times

Time to execute each fully robotic anastomosis. \*Please note - three participants underwent a Free Flap and LVA surgery and therefore are accounted for in each cohort.

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=274 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) n=129 Participants Patients undergoing a LVA surgery	Replantation n=12 Participants Patients undergoing replantation surgery
Anastomosis Time	35.6 duration robotic anastomosis (minutes) Standard Deviation 15.15	30.8 duration robotic anastomosis (minutes) Standard Deviation 12.63	20.6 duration robotic anastomosis (minutes) Standard Deviation 10.61

SECONDARY outcome

Timeframe: Procedure

Population: Anastomoses that met the criteria for needing to be redone intraoperatively.

Intraoperative need to repeat anastomosis

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=613 Robotic Anastomosis Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Intraoperative Redo	6.4 Percentage of redos Interval 4.6 to 8.6	—	—

SECONDARY outcome

Timeframe: 7 days

Population: This denominator for this analysis is the number of patients in the FAS

Post-operative redos were identified as the need to return to the operating room to explore anastomosis.

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=412 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Percentage of Participants With Postoperative Redo Within 7 Days	2.9 percentage of participants Interval 1.5 to 5.0	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of robotic procedures for which surgeons completed the study questionnaire

Surgeons were asked to complete a questionnaire for each patient operated on using the study device. Success was defined as a response of complete or partial procedure success.

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=231 robotic procedure Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) n=110 robotic procedure Patients undergoing a LVA surgery	Replantation n=12 robotic procedure Patients undergoing replantation surgery
Surgeon Assessment of Robotic Usability	97.0 % of successfull robotic procedures Interval 93.9 to 98.9	96.4 % of successfull robotic procedures Interval 91.0 to 99.0	100 % of successfull robotic procedures Interval 73.5 to 100.0

SECONDARY outcome

Timeframe: discharge

This effectiveness endpoint is assessed only for free flap procedures undertaken in the FAS. Subjects were assessed at the time of discharge for free flap survival status.For patients with free flap procedures, the average hospital stay was 11.9 days.

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=274 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Free Flap Survival at Discharge	97.8 percentage of free flap survival Interval 95.3 to 99.2	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Not all participants undergoing LVA were assessed for limb volume change

Limb volume reduction

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=92 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Limb Volume Reduction (for Lymphatic Surgery)	-4.7 Percentage change from baseline Standard Deviation 15.61	—	—

SECONDARY outcome

Timeframe: Procedure

Population: Not all participants undergoing free flap were assessed for warm ischemia time.

Time for warm ischemia

Outcome measures

Outcome measures
Measure	Robotic Assisted Microsurgery n=255 Participants Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. Symani Surgical System: Robotically Assisted Microsurgery	Lymphaticovenous Anastomosis (LVA) Patients undergoing a LVA surgery	Replantation Patients undergoing replantation surgery
Warm Ischemia Time	113 minutes Standard Deviation 46.9	—	—

Adverse Events

Free Flap

Serious events: 20 serious events

Other events: 51 other events

Deaths: 0 deaths

Lymphaticovenous Anastomosis (LVA)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Replantation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Free Flap n=274 participants at risk Patients undergoing Free Flap surgery	Lymphaticovenous Anastomosis (LVA) n=129 participants at risk Patients undergoing a LVA surgery	Replantation n=12 participants at risk Patients undergoing replantation surgery
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.2% 6/274 • Number of events 7 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Vascular disorders Vascular disorders	1.8% 5/274 • Number of events 5 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Surgical and medical procedures Surgical and medical procedures	1.8% 5/274 • Number of events 5 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Gastrointestinal disorders Gastrointestinal disorders	0.73% 2/274 • Number of events 2 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Cardiac disorders Dyspnoea	0.00% 0/274 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
General disorders Infected seroma	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Metabolism and nutrition disorders Acidosis	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/274 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Nervous system disorders Transient ischaemic attack	0.00% 0/274 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Renal and urinary disorders Acute kidney injury	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)

Other adverse events

Other adverse events
Measure	Free Flap n=274 participants at risk Patients undergoing Free Flap surgery	Lymphaticovenous Anastomosis (LVA) n=129 participants at risk Patients undergoing a LVA surgery	Replantation n=12 participants at risk Patients undergoing replantation surgery
Cardiac disorders Cardiac disorders	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
General disorders General disorders	0.73% 2/274 • Number of events 2 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Immune system disorders Drug hypersensitivity	0.00% 0/274 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Blood and lymphatic system disorders Anaemia	1.1% 3/274 • Number of events 3 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Infections and infestations Infections and infestations	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	8.8% 24/274 • Number of events 27 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	3.9% 5/129 • Number of events 5 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Investigations Investigations	0.73% 2/274 • Number of events 2 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/274 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	16.7% 2/12 • Number of events 2 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Nervous system disorders Disturbance in attention	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Product Issues Device Malfunction	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Renal and urinary disorders Acute kidney injury	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.36% 1/274 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.78% 1/129 • Number of events 1 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Surgical and medical procedures Surgical and medical procedures	4.7% 13/274 • Number of events 13 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)
Vascular disorders Vascular disorders	2.9% 8/274 • Number of events 10 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/129 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)	0.00% 0/12 • All adverse events will be collected from the procedure date to the study exit of each subject enrolled, up to 24 weeks Adverse events are summarized by MedDRA dictionary system organ class (SOC) and preferred term (PT)

Additional Information

Clinical Operations

Medical Microinstruments

Phone: 8336646276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place