Trial Outcomes & Findings for EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence (NCT NCT04236245)
NCT ID: NCT04236245
Last Updated: 2022-04-04
Results Overview
Percentage of limbs with occlusion of the treated vein
COMPLETED
NA
25 participants
3 days
2022-04-04
Participant Flow
Participant milestones
| Measure |
Venclose RF System
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Baseline characteristics by cohort
| Measure |
Venclose RF System
n=25 Participants
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs with occlusion of the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Vein Occlusion Rate
Complete Occlusion
|
29 limbs
|
|
Vein Occlusion Rate
Segmental Recanalization
|
0 limbs
|
|
Vein Occlusion Rate
Complete Recanalization
|
0 limbs
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs with occlusion of the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Vein Occlusion Rate
Complete Occlusion
|
28 Limbs
|
|
Vein Occlusion Rate
Segmental Recanalization
|
1 Limbs
|
|
Vein Occlusion Rate
Complete Recanalization
|
0 Limbs
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs with occlusion of the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Vein Occlusion Rate
Complete Occlusion
|
28 Limbs
|
|
Vein Occlusion Rate
Segmental Recanalization
|
1 Limbs
|
|
Vein Occlusion Rate
Complete Recanalization
|
0 Limbs
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs with occlusion of the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Vein Occlusion Rate
Segmental Recanalization
|
1 Limbs
|
|
Vein Occlusion Rate
Complete Occlusion
|
28 Limbs
|
|
Vein Occlusion Rate
Complete Recanalization
|
0 Limbs
|
PRIMARY outcome
Timeframe: 3 daysPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs without reflux in the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Reflux-free Rate
No reflux along treated GSV
|
29 Limbs
|
|
Reflux-free Rate
Reflux along treated GSV
|
0 Limbs
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs without reflux in the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Reflux-free Rate
No reflux along treated GSV
|
28 Limbs
|
|
Reflux-free Rate
Reflux along treated GSV
|
1 Limbs
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs without reflux in the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Reflux-free Rate
No reflux along treated GSV
|
28 Limbs
|
|
Reflux-free Rate
Reflux along treated GSV
|
1 Limbs
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Percentage of limbs without reflux in the treated vein
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Reflux-free Rate
No reflux along treated GSV
|
28 Limbs
|
|
Reflux-free Rate
Reflux along treated GSV
|
1 Limbs
|
SECONDARY outcome
Timeframe: BaselinePopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C0: No visible or palpable signs of venous disease
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C1: Telangiectasies or reticular veins
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C2: Varicose veins
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C3: Edema
|
24 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4a: Pigmentation or eczema
|
4 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4b: Lipodermatosclerosis or atrophie blanche
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C5: Healed venous ulcer
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C6: Active venous ulcer
|
0 Limbs
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C0: No visible or palpable signs of venous disease
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C1: Telangiectasies or reticular veins
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C2: Varicose veins
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C3: Edema
|
24 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4a: Pigmentation or eczema
|
3 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4b: Lipdermatosclerosis or atrophie blanche
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C5: Healed venous ulcer
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C6: Active venous ulcer
|
0 Limbs
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C0: No visible or palpable signs of venous disease
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C1: Telangiectasies or reticular veins
|
11 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C2: Varicose veins
|
10 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C3: Edema
|
4 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4a: Pigmentation or eczema
|
2 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4b: Lipodermatosclerosis or atrophie blanche
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C5: Healed venous ulcer
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C6: Active venous ulcer
|
0 Limbs
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C0: No visible or palpable signs of venous disease
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C1: Telangiectasies or reticular veins
|
19 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C2: Varicose veins
|
5 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C3: Edema
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4a: Pigmentation or eczema
|
2 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4b: Lipodermatosclerosis or atrophie blanche
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C5: Healed venous ulcer
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C6: Active venous ulcer
|
0 Limbs
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C0: No visible or palpable signs of venous disease
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C1: Telangiectasies or reticular veins
|
21 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C2: Varicose veins
|
3 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C3: Edema
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4a: Pigmentation or eczema
|
2 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C4b: Lipodermatosclerosis or atrophie blanche
|
0 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C5: Healed venous ulcer
|
1 Limbs
|
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
C6: Active venous ulcer
|
0 Limbs
|
SECONDARY outcome
Timeframe: BaselinePopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Venous Clinical Severity Score (VCSS)
|
4.4 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Venous Clinical Severity Score (VCSS)
|
5.9 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Venous Clinical Severity Score (VCSS)
|
1.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Venous Clinical Severity Score (VCSS)
|
0.7 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Venous Clinical Severity Score (VCSS)
|
0.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: up to 3 daysPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Presence of Complications From GSV Intervention
Allergic reaction to local anesthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Allergic reaction to device
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Vein perforation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Thermal skin injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Skin discoloration or pigmentation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Infection
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Neurological injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Paresthesia
|
1 Limbs
|
|
Presence of Complications From GSV Intervention
Superficial venous thrombophlebitis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Edema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Ecchymosis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Hematoma
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Erythema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
EHIT II (non-occlusive DVT)
|
1 Limbs
|
|
Presence of Complications From GSV Intervention
Deep vein thrombosis (DVT) or pulmonary embolism (PE)
|
0 Limbs
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Presence of Complications From GSV Intervention
Allergic reaction to local anesthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Allergic reaction to device
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Vein perforation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Thermal skin injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Skin discoloration or pigmentation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Infection
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Neurological injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Paresthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Superficial venous thrombophlebitis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Edema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Ecchymosis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Hematoma
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Erythema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
EHIT II (non-occlusive DVT)
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Deep vein thrombosis (DVT) or pulmonary embolism (PE)
|
0 Limbs
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Presence of Complications From GSV Intervention
Allergic reaction to local anesthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Allergic reaction to device
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Vein perforation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Thermal skin injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Skin discoloration or pigmentation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Infection
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Neurological injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Paresthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Superficial venous thrombophlebitis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Edema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Ecchymosis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Hematoma
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Erythema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
EHIT II (non-occlusive DVT)
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Deep vein thrombosis (DVT) or pulmonary embolism (PE)
|
0 Limbs
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Outcome measures
| Measure |
Venclose RF System
n=29 Limbs
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Presence of Complications From GSV Intervention
Infection
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Paresthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Allergic reaction to local anesthesia
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Allergic reaction to device
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Vein perforation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Thermal skin injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Skin discoloration or pigmentation
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Neurological injury
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Superficial venous thrombophlebitis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Edema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Ecchymosis
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Hematoma
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Erythema
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
EHIT II (non-occlusive DVT)
|
0 Limbs
|
|
Presence of Complications From GSV Intervention
Deep vein thrombosis (DVT) or pulmonary embolism (PE)
|
0 Limbs
|
Adverse Events
Venclose RF System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Venclose RF System
n=25 participants at risk
Treatment of great saphenous vein (GSV) using Venclose RF System
Venclose RF System: Treatment of great saphenous vein (GSV) using Venclose RF System
|
|---|---|
|
Vascular disorders
Non-occlusive DVT
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected from time of treatment through one year.
|
|
Vascular disorders
Muscle vein thrombosis
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from time of treatment through one year.
|
|
Vascular disorders
Pain
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from time of treatment through one year.
|
|
Blood and lymphatic system disorders
Lymphedema
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from time of treatment through one year.
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from time of treatment through one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60