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LIST OF CLINICAL INVESTIGATIONAL USE STUDIES

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Notification for Exemption from Registration of Medical Devices for the Purpose of Clinical Investigational Use

No.

CIP No

Title

Applicant

Investigational Device

Study Site

Study Starts

Study Ends

Status

1

CT2014-01

Performance and Safety of An Improved Model of HD Integra Central Concentrate System (CCS): An open label randomized active-controlled cross over study to demonstrate the equivalence of HD Integra CCS and Pre-Produced Concentrate for Use in Chronic Haemodialysis for patients with End-stage Renal Disease

JKS Biomedical Sdn. Bhd.

HD Integrea Central Concentreate System (CCS)

ClinResearch Sdn. Bhd.

DaVita Malaysia  (Quality Dialysis Centre)

KPJ Ipoh  Specialist Hospital

29 September 2014

17 November 2015

Completed

2

NO. 4 (22/05/2016)

Antimicrobial Nanostructured Noble Metal Coating for Orthopaedic Implants

Vigilenz Medical Devices Sdn Bhd

Orthosyn: Antibacterial Bacteriostatic Orthopedic Implant

Department of Orthopaedic, Hospital Sultanah Aminah

1 September 2016

12 November 2019

Completed

3

XEL-CR-01

Prospective, Non-Randomised, Open Label Clinical Study to Assess the Safety of The Bioabsorbable Pulmonary Valved Conduit (PV-001) In Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Cardiothoracic Surgery Department,

Institut Jantung Negara (IJN)

PV-001: Bioabsorbable Pulmonary Valved Conduit

Institut Jantung Negara (IJN)

August 2016

December 2021

Ongoing

4

31514

Initial Clinical Experience with Trumpet ART stent: An evaluation of a flexible self-expandable metallic stent for advanced cardioesophageal junction carcinoma.

Department of Surgery,

Hospital Tuanku Ja’afar Seremban

Hanarostent: Trumpet ART Stent

Department of Surgery, Hospital Tuanku Jaafar, Seremban

October 2016

October 2017

Completed

5

IJNREC/ 228/2017

Attain StabilityTM Quad Clinical Study

Medtronic Malaysia Sdn Bhd

Attain StabilityTM Quad MRI SureScanTM 4798-000cm: CRT Lead

Institut Jantung

Negara (IJN)

23 June 2017

31 January 2019

Completed

6

IJNREC/ 227/ 2017

Micro Atrial Tracking Using a Ventricular Accelerometer (MARVEL)

Medtronic Malaysia Sdn Bhd

PV-001: Bioabsorbable Pulmonary Valved Conduit

Institut Jantung Negara (IJN)

23 June 2017

31 March 2018

Completed

7

RCP/ 2017/ IRG-IK/ 001

A Prospective, Randomised, Multi-centre, Parallel-group Study to Determine Effects of Pressurised Lavage using WoundjetTM Versus Conventional Swabbing in Cleaning Wounds that Heal by Primary or Secondary Intention in the Emergency Room Setting

RC Precision Engineering Sdn Bhd

WoundjetTM: Wound Cleaning System

Hospital Pulau Pinang

Hospital Sultanah Bahiyah

1 June 2017

30 November 2017

Completed

8

ILS- CIP- 001

Rev-02

Buffered GEnipin Microinvasive Device for Treatment of Low Back Pain from Degenerative Disc Disease – Clinical Safety Evaluation

LMH Biotech Sdn Bhd

Réjuve System: Injectable Crosslinking Biomaterial for Mechanical/Structural Support of Collagen Tissues

Pantai Hospital Kuala Lumpur

May 2017

May 2018

Completed

9

Version 2.1

Comparison of Stethee to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds: A Multicentre, Randomised, Crossover, Non-Inferiority Trial

Clinical Research Centre Perak

Stethee Electronic Stethoscope

Clinical Research Centre, Hospital Raja Permaisuri Bainun, Perak

January 2018

23 October 2019

Completed

10

8151- 01- 2/1

Evaluation of The Xpert Fingerstick HCV Viral Load (VL) Assay

Clinical Research Malaysia

GeneXpert IV System

Hospital Selayang

4 December 2017

4 March 2018

Completed

11

OPM-G-H-1705

Randomized Controlled Multicentre Study to Evaluate the Performance of a New 2-Piece Ostomy Appliance Vs Flexima® 3S In Patients with Enterostomy

B. Braun Medical Industries Sdn. Bhd

Flexima 3S tape border

Universiti Malaya Medical Centre

Hospital Selayang

January 2018

21 January 2020

Completed

12

XEL-CR-02

Prospective, Non-Randomised, Open Label Clinical Study to Assess the Safety and Performance of The Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

(Xpand-CR)

Cardiothoracic Surgery Department,

Institut Jantung Negara (IJN)

PV-001: Xeltis Pulmonary Valved Conduit

Institut Jantung Negara

15 May 2018

31 December 2024

Ongoing

13

MDT17027DCB001

A Clinical Performance Evaluation of a New Medtronic Coronary Drug-Coated Balloon Catheter for The Treatment Of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries; The PREVAIL Study.

Medtronic Malaysia Sdn Bhd

DCB: Medtronic Coronary Drug-coated Balloon Catheter RX

Sarawak Heart Centre

Sabah Heart Centre

1 July 2018

30 September 2020

Early terminated on 13th August 2018 due to site in Europe has met enrolment target and closed for new recruitment.

14

KLS18-XMO-093

An open label, randomized, parallel, safety and efficacy design study in subjects undergoing PCNL procedure with ANT device or manual access for kidney stone procedure

MyXMO Sdn Bhd

ANT:  Automated Needle Targeting for automated lesion targeting

Universiti Malaya Medical Centre

29 August 2018

29 September 2018

Completed

15

CT001-SKP-1701

A Prospective, Comparative Study to Evaluate the Accuracy of Bilirubinometer (RECOVE) with Dräger JM103 and Conventional Blood testing in Measuring Bilirubin levels in new-borns with Jaundice in Malaysia

Recove Group Sdn. Bhd.

Propriety Bilirubinometer Device

Klinik Kesihatan Pandamaran, Klang

November 2018

22 October 2019

Completed

16

IBS-IJN-MY

Feasibility, efficacy and safety of IBS Angel for implantation in the PDA in duct-dependent cyanotic CHD

MediSenseAsia Sdn Bhd

IBSTM Angel Iron Bioresorbable Scaffold System

Institut Jantung Negara (IJN)

August 2019

August 2020

Completed

17

MARVEL 2 Study

Micra Atrial Tracking using a Ventricular Accelerometer (MARVEL) 2 Study.

Medtronic Malaysia Sdn Bhd

ER220 Extended Range Holter Monitor of MARVEL 2 Research System

Institut Jantung Negara (IJN)

15 January 2019

5 January 2020

Completed

18

IBS-FIM-MY

A Prospective, Non-randomised, Open-label, Non-comparative, First in Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron

MediSenseAsia Sdn Bhd

Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System

Institut Jantung Negara (IJN)

University Malaya Medical Centre

March 2019

March 2020

Completed

19

MDT18054

Ventricle from Atrium Heart Failure (VFAHF) Clinical Study

Medtronic Malaysia Sdn Bhd

ECG Belt System

Institut Jantung Negara

06 August 2019

01 June 2020

Completed

20

UKM/PP1/111/8/JEP-2018-417

Clinical Validation and Sensitivity Optimisation of a Non-Invasive Finger Touch Blood Glucose Meter "Glucosenz" And Comparing Values of Blood Glucose Levels as Assessed By "Glucosenz" With Those Obtained Via Glucose Test Strip Method or Glucose Oxidase Method

OSA Technology Sdn.  Bhd.

Glucosenz:  Non-Invasive Blood Glucose Sensor

Hospital Canselor Tuanku Muhriz UKM Medical Centre

01 August 2018

31 July 2020

Completed

21

ADIPOLAB001

Hyperthermia in Treating Patients with Painful Unresectable Abdominal or Pelvic Malignancy

Adipolabs Healthcare (M) Sdn Bhd

REMISSION 1°C: A high frequency hyperthermia equipment

University Malaya Medical Centre

31 December 2019

31 December 2021

Ongoing

22

XN-31

Evaluation Validation of An Automated Malaria Detection System Via Haematology Flow Cytometry

Sysmex (Malaysia) Sdn Bhd

Sysmex XN-31 analyser

Hospital Kapit, Sarawak

01 March 2020

28 February 2022

Ongoing

23

QM-IS-UTB-035

A Prospective, Multicentric, Single Arm Study to Evaluate the Safety and Efficacy of The Unity-B Biodegradable Balloon Expandable Biliary Stent System in Subjects with Biliary Strictures

Vitramed (Asia) Sdn. Bhd.

UNITY-B: Biodegradable Balloon Expandable Biliary Stent System

Sunway Medical Centre

University of Malaya Medical Centre

15 June 2020

31 December 2020

Completed

24

ADIPOLAB002

Immune Modulatory Effect of Hyperthermia During Treatment of Recurrent or Metastatic Solid Organ Malignancies

Adipolabs Healthcare (M) Sdn. Bhd

REMISSION 1°C: A high frequency hyperthermia equipment

University Malaya Medical Centre

01 March 2020

31 December 2021

Ongoing

25

27062019

Risk Stratification of Chest Pain Patients Using Heart Rate Variability and Heart Score

Global Healthcare Sg Sdn. Bhd

aiTriage™ Risk Stratification System for Triage Software V1.0

Faculty of Medicine, UITM Sungai Buloh Campus

03 April 2020

05 April 2021

Completed

26

VERSION 2.0

The Heart Beat of The Nation: A Cross-Sectional Study of Normal Heart Sounds Using Ai Enabled Electronic Stethoscope

National Institutes of Health (NIH)

Stethee Pro 1 Electronic Stethoscope

All primary health clinics within the Ministry of Health

04 January 2021

03 January 2023

Ongoing

27

XEL-CR-03

Prospective, Non-Randomized Pivotal Clinical Study to Assess the Safety and Efficacy of The Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Institut Jantung Negara (IJN)

PV-001: Bioabsorbable Pulmonary Valved Conduit

Institut Jantung Negara (IJN)

15 September 2020

01 September 2025

Ongoing

28

XEL-CR-07

Prospective, Non-Randomized, First in Human (FIH) Clinical Study to Assess the Feasibility of The Novel Xeltis Coronary Artery Bypass Graft (XABG)

Institut Jantung Negara (IJN)

XABG: The Xeltis Coronary Artery Bypass Graft

Institut Jantung Negara (IJN)

15 September 2020

31 September 2026

Ongoing

29

VERSION REVISION 2.0, 22-07-2020

The Development and Feasibility Study Of 3d Printed Material Use in Nasopharyngeal Swab for COVID-19 Testing

Universiti Sains Islam Malaysia (USIM)

USIM 3D Printed Nasal Swab

Isolation Ward COVID-19 Hospital Kuala Lumpur

01 September 2020

30 September 2020

Completed

30

TRACIE-MY-01

Portable Breathalyzer for Rapid COVID-19 Detection

M & B Healthcare Sdn Bhd

TRACIE: Tracking Respiratory Air Components

Instantly and Effectively Breathalyzer

Hospital Queen Elizabeth

Hospital Sungai Buloh

10 February 2021

10 March 2022

Ongoing

31

MDT19004

Lead Evaluation for Defibrillation and Reliability (LEADR)

Medtronic Malaysia Sdn Bhd

Next Generation ICD lead:  Implantable Cardioverter Defibrillator (ICD) lead

Institut Jantung Negara (IJN)

15 April 2021

15 April 2024

Ongoing

32

REF: 01/TLB/2021

The Clinical Safety and Performance of TL Dental Needle Among Experienced Dental Practitioners. A Study in USM and UM.

TL Borneo Sdn. Bhd

TL Dental Needle

Universiti Sains Malaysia

Universiti Malaya

01 June 2021

31 December 2021

Ongoing

33

IPMX-MY-01

Clinical Evaluation of IPMX Molecular Rapid Screening System for SARS-COV-2

Innosignum Sdn. Bhd

SARS-Cov-2 IPMX Molecular Rapid Test System

Hospital Sungai Buloh

01 April 2021

30 June 2022

Ongoing

34

NTSB/MD/01-01-CIP-01 VERSION 1

A Prospective, Open Label, Randomized, Double Arm, Multicenter Study to Evaluate the Performance of Nitident Tuah Porous NITI Dental Implants in Single Tooth Gap in The Posterior Mandible

Nitium Technology Sdn. Bhd

Nitident Tuah Porous NITI Dental Implant

Faculty of Dentistry, UITM Sungai Buloh Campus

Faculty of Dentistry, University Malaya

Faculty of Dentistry, University Kebangsaan Malaysia

1 September 2021

1 May 2023

Ongoing

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