## Protocol Section
### Identification Module
**NCT ID:** NCT06436807

**Brief Title:** PMCF Study of the CE-marked Drainova® ArgentiC Catheter

**Official Title:** Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter

#### Organization Study ID Info
**ID:** 23-079
#### Organization
**Class:** INDUSTRY
**Full Name:** ewimed GmbH
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** LS medcap GmbH

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ewimed GmbH

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.

The main questions of this study are:

* Does the device function as intended?
* Are there any other safety risks that have not been identified?
* Does it lower the symptoms of the patients as intended?

Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.

**Detailed Description:** The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU).

This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.

### Conditions Module

**Conditions:**

- Pleural Effusion

- Pleural Effusion, Malignant

- Ascites

- Ascites, Malignant

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 162

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** The tunneled catheter is an implant product that enables the drainage of effusion accumulations from serous body cavities so that the symptoms caused by an effusion are relieved by draining off the accumulated fluids.

**Name:** Indwelling catheter

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).

**Measure:** Ascites- and pleural effusion-associated symptom relief

**Time Frame:** Discharge (1-7 days post-implantation)

**Description:** Occurrence of catheter blockage, occlusion or displacement

**Measure:** Catheter patency

**Time Frame:** Discharge (1-7 days post-implantation)

**Description:** Must meet the following items:

1. Successful placement at the defined location
2. Feasibility of initial drainage of fluid (volume in ml)

**Measure:** Implantation success

**Time Frame:** Immediately after procedure

**Description:** Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies

**Measure:** Incidence of major adverse events, infections and device deficiencies

**Time Frame:** Up to three months post-implanatation

#### Secondary Outcomes

**Description:** Quality-of-life will be assessed by QoL questionnaire

**Measure:** Improvement of the patients´ quality-of-life vs. baseline

**Time Frame:** discharge (1-7 days post-implantation), 30 days, 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients ≥ 18 years old
* Patients being able to give informed consent

Exclusion Criteria:

Patients with any contraindication according to the IFU:

* presence of septa in the body cavity
* coagulopathy
* infection in the body cavity
* lymphatic effusion
* shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
* known allergies to any of the materials used in the drainage product

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** natasa.mitrovic@lsmedcap.com

**Name:** Natasa Mitrovic, MSc

**Phone:** +49 7471 9849 9529

**Role:** CONTACT

**Contact 2:**

**Email:** heidrun.steinle@lsmedcap.com

**Name:** Heidrun Steinle, Dr

**Phone:** +49 7471 9848 0175

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** LS medcap GmbH

**Name:** Heidrun Steinle, Dr

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010995

- Term: Pleural Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010997

- Term: Pleural Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M18563

- Name: Pleural Effusion, Malignant

- Relevance: HIGH

- As Found: Pleural Effusion, Malignant

- ID: M13886

- Name: Pleural Effusion

- Relevance: HIGH

- As Found: Pleural Effusion

- ID: M4509

- Name: Ascites

- Relevance: HIGH

- As Found: Ascites

- ID: M13885

- Name: Pleural Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13887

- Name: Pleural Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016066

- Term: Pleural Effusion, Malignant

- ID: D000010996

- Term: Pleural Effusion

- ID: D000001201

- Term: Ascites

### Misc Info Module

- Version Holder: 2024-05-31
