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The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.
The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seg. RF Ablation with CLF catheter | Experimental | Single Arm with CLF Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation (ClosureFAST) | Device | Segmental RF Ablation with the CLF catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure. | 6 Months |
| Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 12 months |
| Percentage of Limbs Without Vein Occlusion | Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan. | 2 years |
| Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 3 years |
| Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 4 years |
| Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. |
| Measure | Description | Time Frame |
|---|---|---|
| CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The "CEAP" classification. Mayo Clinic Proc 1996;71:338-45. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Hasenbank, PhD | Medtronic | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26992304 | Derived | Proebstle TM, Mohler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6. |
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Recruitment from April 24, 2006- September 5, 2006. Medical offices/clinics and university hospital.
| ID | Title | Description |
|---|---|---|
| FG000 | ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei | Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
326 patients were enrolled and 396 limbs were treated and are analyzed. Only 395 limbs provided baseline CEAP data.
| ID | Title | Description |
|---|---|---|
| BG000 | ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei | Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure. | 363 limbs were available for primary outcome measure evaluation at the 6M timepoint. | Posted | Mean | Standard Error | percentage of limbs | 6 Months | limbs | limbs |
|
5 years
SAEs were collected through study closure at 5 years. An SAE was defined as any AE that led to death, to a serious deterioration in the health of a subject that resulted in a life-threatening injury, a permanent impairment of a body structure/body function, hospitalization or prolongation of existing hospitalization, in a medical or surgical intervention to prevent permanent impairment of body structures or a body function; or led to fetal distress, fetal death, or a congenital birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei | Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Bleed | Gastrointestinal disorders | GI Bleed | Systematic Assessment | Unrelated event, Fatal GI Bleed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Brucato, Principal Clinical Research Specialist | Medtronic | 508-261-8000 | stephanie.m.brucato@medtronic.com |
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| 5 years |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 6 months |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 12 months |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 2 years |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 3 years |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 4 years |
| Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 5 years |
| Baseline |
| CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | 1 Week |
| CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | 3 months |
| CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | 12 months |
| CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | 5 years |
| Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up | Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0). Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12. | Baseline thru 5 years |
| Visual Analog Pain Scale (VAS) | Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain | 5 years |
| Presence of Complications From Greater Saphenous Vein (GSV) Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 1 Week |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 3 Months |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 12 months |
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 5 years |
| limbs |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| CEAP | CEAP (Clinical/Etiology/Anatomy/Pathophysiology) Clinical Score: C0: No visible/palpable sign C1: Reticular spider veins C2: Simple varicose veins C3: Ankle edema C4: Skin pigmentation C5: Healed venous ulcer C6: Open venous ulcer 395 out of 396 limbs reported a Baseline CEAP score. | only 395 out of 396 limbs reported a Baseline CEAP score | Number | limbs | limbs |
|
|
| Units | Counts |
|---|
| Participants |
|
| limbs |
|
|
| Primary | Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 350 limbs were evaluated at the 12M timepoint | Posted | Mean | Standard Error | percentage of limbs | 12 months | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Vein Occlusion | Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan. | Out of the limbs treated 329 limbs were available for a Duplex Ultrasound scan at the 2Y follow-up | Posted | Mean | Standard Error | percentage of limbs | 2 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 293 limbs were evaluated at the 3Y timepoint | Posted | Mean | Standard Error | percentage of limbs | 3 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 275 limbs were evaluated at the 4Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 4 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Vein Occlusion | Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure. | 279 limbs were evaluated at the 5Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 5 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 363 limbs were evaluated at the 6M timepoint | Posted | Mean | Standard Error | Percentage of limbs | 6 months | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 350 limbs were evaluated at the 12M timepoint | Posted | Mean | Standard Error | Percentage of limbs | 12 months | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 329 limbs were evaluated at the 2Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 2 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 293 limbs were evaluated at the 3Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 3 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 275 limbs were evaluated at the 4Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 4 years | limbs | limbs |
|
|
|
| Primary | Percentage of Limbs Without Reflux in the Treated Vein Segment | No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation. | 279 limbs were evaluated at the 5Y timepoint | Posted | Mean | Standard Error | Percentage of limbs | 5 years | limbs | limbs |
|
|
|
| Secondary | CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The "CEAP" classification. Mayo Clinic Proc 1996;71:338-45. | Posted | Count of Units | limbs | Baseline | limbs | limbs |
|
|
|
| Secondary | CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | Posted | Count of Units | limbs | 1 Week | limbs | limbs |
|
|
|
| Secondary | CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | Only 302 subjects (371 limbs) completed the 3 Month follow-up visit to provide data to this outcome measure. | Posted | Count of Units | limbs | 3 months | limbs | limbs |
|
|
|
| Secondary | CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | Only 280 subjects (350 limbs) completed the 12 Month follow-up visit to provide data to this outcome measure. | Posted | Count of Units | limbs | 12 months | limbs | limbs |
|
|
|
| Secondary | CEAP Classification | Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status. | Only 221 subjects (279 limbs) completed the 5 Year follow-up visit to provide data to this outcome measure. | Posted | Count of Units | limbs | 5 years | limbs | limbs |
|
|
|
| Secondary | Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up | Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0). Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12. | Posted | Mean | Standard Deviation | VCSS Score | Baseline thru 5 years | limbs | limbs |
|
|
|
| Secondary | Visual Analog Pain Scale (VAS) | Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain | Posted | Mean | Standard Deviation | units on a scale (0-10) | 5 years | limbs | limbs |
|
|
|
| Secondary | Presence of Complications From Greater Saphenous Vein (GSV) Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | Posted | Count of Units | limbs | 1 Week | limbs | limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | Posted | Count of Units | limbs | 3 Months | limbs | limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | Posted | Count of Units | limbs | 12 months | limbs | limbs |
|
|
|
| Secondary | Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | Posted | Count of Units | limbs | 5 years | limbs | limbs |
|
|
|
| 2 |
| 326 |
| 10 |
| 326 |
| 0 |
| 326 |
|
| Thrombus extensions | Vascular disorders | Thrombus extension | Systematic Assessment | Thrombus extensions into the Common Femoral vein (CFV) |
|
| Pulmonary Emboli (PE) | Vascular disorders | Pulmonary Emboli | Systematic Assessment | Pulmonary Emboli (PE) |
|
| Death (Unknown Cause) | General disorders | Systematic Assessment |
|
Not provided
| C3 |
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| C4 |
|
| C5 |
|
| C6 |
|
| Title | Measurements |
|---|
|
| C3 |
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| C4 |
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| C5 |
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| C6 |
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| C3 |
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| C4 |
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| C5 |
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| C6 |
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| C3 |
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| C4 |
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| C5 |
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| C6 |
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| C3 |
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| C4 |
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| C5 |
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| C6 |
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| C3 |
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| C4 |
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| C5 |
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| C6 |
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| Title | Measurements |
|---|---|
|
| 6 months |
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| 12 months |
|
| 2 years |
|
| 3 years |
|
| 4 years |
|
| 5 years |
|
| Title | Measurements |
|---|---|
|
| 12 months |
|
| 2 years |
|
| 3 years |
|
| 4 years |
|
| 5 years |
|
| Title | Measurements |
|---|
|
| Infection |
|
| Pain |
|
| Paresthesia |
|
| Phlebitis |
|
| Skin Pigmentation |
|
| Thermal Skin Injury |
|
| Thrombus Extension / DVT |
|
| Title | Measurements |
|---|
|
| Infection |
|
| Pain |
|
| Paresthesia |
|
| Phlebitis |
|
| Skin Pigmentation |
|
| Thermal Skin Injury |
|
| Thrombus Extension / DVT |
|
| Title | Measurements |
|---|
|
| Infection |
|
| Pain |
|
| Paresthesia |
|
| Phlebitis |
|
| Skin Pigmentation |
|
| Thermal Skin Injury |
|
| Thrombus Extension / DVT |
|
| Title | Measurements |
|---|
|
| Infection |
|
| Pain |
|
| Paresthesia |
|
| Phlebitis |
|
| Skin Pigmentation |
|
| Thermal Skin Injury |
|
| Thrombus Extension / DVT |
|