## Protocol Section
### Identification Module
**NCT ID:** NCT06418282

**Acronym:** GRANDE

**Brief Title:** Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

**Official Title:** An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

#### Organization Study ID Info
**ID:** KCT 013 (GRANDE)
#### Organization
**Class:** INDUSTRY
**Full Name:** Koya Medical, Inc.
### Status Module
#### Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Koya Medical, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

**Detailed Description:** An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

### Conditions Module

**Conditions:**

- Phlebolymphedema

- Lymphedema

- Chronic Venous Insufficiency

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.

**Intervention Names:**

- Device: Dayspring

**Label:** Dayspring, Non-Pneumatic Active Compression Device (NPCD)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dayspring, Non-Pneumatic Active Compression Device (NPCD)

**Description:** NPCD

**Name:** Dayspring

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6

**Measure:** Lymphedema Overall Quality of Life and Patient Survey

**Time Frame:** 6 months

**Description:** Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)

**Measure:** Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)

**Time Frame:** 6 months

**Description:** Mobility (daily steps using a pedometer)

**Measure:** Mobility (daily steps using a pedometer)

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Lower extremity edema response (limb girth reduction)

**Measure:** Lower extremity edema response (limb girth reduction)

**Time Frame:** 6 months

**Description:** LE Functional Index (LEFI)

**Measure:** LE Functional Index (LEFI)

**Time Frame:** 6 months

**Description:** Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome

**Measure:** Venous Clinical Severity Score (VCSS)

**Time Frame:** 6 months

**Description:** As assessed by reported adverse events

**Measure:** Safety/Adverse Events

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Males and females ≥ 18 years of age
* Capable and willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
* Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux

Exclusion Criteria:

* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
* Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
* Non-ambulatory individuals
* Female: BMI \> 34 (5'4", 200 lbs.)
* Male: BMI \> 34 (5'9", 230 lbs.)
* (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
* Diagnosis of lipedema
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
* Diagnosis of acute infection (in the last four weeks)
* Diagnosis of active/open wound/ulcer
* Diagnosis of acute thrombophlebitis (in last 2 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled/uncompensated)
* Diagnosis of chronic kidney disease with acute renal failure
* Diagnosis of epilepsy
* Subjects with poorly controlled asthma
* Any condition where increased venous and lymphatic return is undesirable
* Women who are pregnant, planning a pregnancy or nursing at study entry
* Participation in any clinical trial of an investigational substance or device during the past 30 days

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** clinical@koyamedical.com

- **Name:** Glenn Jacobowitz, MD

- **Phone:** 415-851-0337

- **Role:** CONTACT

**Country:** United States

**Facility:** Glenn Jacobowitz

**State:** New York

**Status:** RECRUITING

**Zip:** 10016

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17435

- Name: Venous Insufficiency

- Relevance: HIGH

- As Found: Venous Insufficiency

- ID: M11206

- Name: Lymphedema

- Relevance: HIGH

- As Found: Lymphedema

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014689

- Term: Venous Insufficiency

- ID: D000008209

- Term: Lymphedema

### Misc Info Module

- Version Holder: 2024-05-31
