The objective of this study is to accumulate clinical data on the safety and performance of NBGM200 embolization in patients with degenerative OA of the knee refractory to conservative treatment so as to provide evidence of conformity with…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients achieving clinical success, defined as a 30% or greater
reduction from baseline in KOOS-12 at 6 months.
Secondary outcome
• Change from baseline in pain relief (VAS) at 6 months post-procedure.
• Percentage of patients achieving clinical success, defined as a 30% or
greater reduction from baseline in WORMS at 6 months.
Background summary
Osteoarthritis(OA) is one of the major causes of pain and disability, where
sensitive nerves and sensory nerve hypersensitivity in the inflamed areas due
to cartilage destruction promote the formation of new blood vessels, and these
new blood vessels stimulate surrounding nerve cells, causing and worsening
pain. In the United States, 26.9 million adults suffer from OA, and it is
estimated that 50% of adults will develop severe knee osteoarthritis by the age
of 85.
Treatment for knee OA includes exercise, education, and pharmacological
therapies, including oral, topical, and intra-articular medications. Mild
symptoms can be managed with nonsteroidal anti-inflammatory drugs (NSAIDs), but
severe or end-stage osteoarthritis is treated with total joint arthroplasty.
However, NSAIDs can cause renal failure and, notably, gastrointestinal
bleeding, highlighting the need for new, effective, minimally invasive, and
safe treatments for knee osteoarthritis.
Among these, particulate embolization has been reported as a safe method for
treating bleeding after total knee arthroplasty. Particulate embolization has
been effective in reducing pain in seven patients with refractory tendinopathy
and enthesopathy, with no major complications. Additionally, synovial
embolization in a study of 14 osteoarthritis patients showed pain reduction and
decreased difficulty in movement, with no complications. Recent studies have
shown that in 72 osteoarthritis patients, successful procedures were performed,
with clinical success rates of 86.3% at 6 months and 79.8% at 3 years, and MRI
follow-up showed no signs of osteonecrosis or degenerative changes.
NBGM200 is Class III embolic material that is resorbable within 2-8 hours,
or/and the rate of resorption can be tuned depending on the type of
intervention, and is intended for use in embolization arteries. In addition, If
microcatheter embolization(TAME) to OA knee patients is performed using
NBGM200, it is possible to treat the patient's pain by blocking
hypervascularization (angiogenesis) and inducing the death of nerve cells that
cause pain.
Consequently, it is the only product that can control resorption time and is a
high-elasticity, high-density, and high-cohesive embolic agent product
optimized for microvascular embolism. NBGM200 is an embolic material composed
of gelatin and has a spherical shape and is harmless to the human body because
no chemical crosslinking agent is used during manufacturing.
The reason for setting a 6-month follow-up period in this study is that several
studies have demonstrated that data collected over 6 months is suitable for
evaluating pain improvement. For example, YS Bagla et al. (2019) and B Wang et
al. (2023) evaluated the effects of pain improvement over a 6-month period, and
Y Okuno et al. (2013) evaluated it over 4 months. In particular, a 6-month
follow-up period is widely used in arthritis research to effectively assess the
degree of pain relief.
This study has set a 6-month follow-up period to evaluate the pain relief
effect and safety of the biodegradable product NBGM200. The data collected
during this period is sufficient to evaluate the initial effects of the
treatment, considering the feasibility of the study and resource constraints.
Given the study's resources and costs, a 6-month follow-up period is a
realistic choice that minimizes the burden on the study while allowing for
effective evaluation. The results of this initial study will serve as baseline
data for evaluating long-term effects in future research. Future studies will
aim to more clearly assess long-term effects based on this data.
Therefore, the 6-month follow-up period is considered appropriate for the
study's objectives and sufficient for evaluating the pain improvement effect.
The overall study design is structured to reduce the burden on patients and
proceed as efficiently as possible.
The proposed 6-month follow-up period in this study may pose a significant
burden on participants. However, considering the objectives of the study and
the potential benefits, participants can expect pain relief during the study
period. Participants may also anticipate long-term improvements in their
quality of life by participating in this study, in addition to short-term pain
relief. The expectation that the effects may last for about a year is important
information.
Moreover, the research procedures will be designed in such a way that the
burden associated with the benefits is not excessive. Participants will receive
adequate information and support throughout the study period. Given the
positive outcomes that may result from participation, the benefits and
procedures of the study can be balanced against the potential burden.
Study objective
The objective of this study is to accumulate clinical data on the safety and
performance of NBGM200 embolization in patients with degenerative OA of the
knee refractory to conservative treatment so as to provide evidence of
conformity with Regulation (EU) 2017/745 to obtain a CE certification.
Study design
Prospective, Single-arm, Multinational, Multi-center clinical study
Intervention
NBGM200, developed by NEXTBIOMEDICAL CO., LTD., is Class III embolic material
that is resorbable within 2-8 hours, or/and the rate of resorption can be tuned
depending on the type of intervention, and is intended for use in embolization
of arteries. In addition, it is the only product in the world that can control
resorption time and is a high-elasticity, high-density, and high-cohesive
embolic agent product optimized for microvascular embolism. It is an embolic
material composed of gelatin and has a spherical shape and is harmless to the
human body because no chemical crosslinking agent is used during manufacturing.
Musculoskeletal Embolization (MSKE) can cause various side effects (skin
discoloration, necrosis) because the blood vessels in the treated area are thin
and close to the skin. However, since NBGM200 temporarily occludes blood
vessels, it is very unlikely to cause tissue necrosis or skin discoloration. In
the case of non-degradable embolic agents, tissue necrosis and skin
discoloration have been reported as side effects of embolization, whereas in
the case of NBGM200, side effects such as skin discoloration or skin ulceration
have not occurred in patients who have undergone embolization so far.
This clinical investigation is designed to accumulate clinical data on the
performance and safety of NBGM200 in patients with knee degenerative
osteoarthritis.
Study burden and risks
During the six-month clinical trial, participants will undergo various
examinations and examinations such as follows:
- one blood analysis and pregnancy test (using minimal amount of blood and
urine),
- two physical examinations,
- three vital signs measurements,
- one medical/surgical history survey,
- one demographic survey,
- one X-ray scan (radiation dose 0.005 mSv),
- two MRI scans,
- eight surveys for concomitant drugs and treatments,
- eight surveys for VAS, KOOS-12,
- and adverse reactions.
These may cause temporary physical/physiological discomfort or unexpected
adverse events. However, embolization has the advantage of reducing knee pain
that does not respond to conservative treatment, and this improvement in knee
pain can last for more than a year on average.
6, Venture-ro 100 beon-gil
Yeonsu-gu, Incheon 22013
KR
6, Venture-ro 100 beon-gil
Yeonsu-gu, Incheon 22013
KR
Listed location countries
Age
Inclusion criteria
Patients must satisfy all of the following inclusion criteria.
1) Adult men and women aged 50 years and over.
2) Osteoarthritis proven by MR-imaging.
3) Kellgren-Lawrence (KL) grade 1-3.
4) Visual Analogue Scale (VAS) pain score of >=5 (on a scale of 0 to 10).
5) Patients who do not respond to conservative therapies (including exercise,
weight loss, pharmacological agents, transcutaneous electrical nerve
stimulation, knee bracing, foot orthoses, thermotherapy, oral supplements, or
dry needling) for at least 24 weeks prior to receiving Musculoskeletal
Embolization (MSKE).
Exclusion criteria
Patients with one or more of the following criteria should not be included in
this trial.
1) Significant intra-articular lesions that could be the cause of complaints or
KL grade 4 OA.
2) Current local infection.
3) Life expectancy less than 6 months.
4) Known advanced atherosclerosis, with known lower extremity vascular or lower
extremity symptoms thought to be secondary to arterial vascular disease (e.g.,
claudication or ischemic rest pain).
5) Rheumatoid or infectious arthritis.
6) Prior knee replacement surgery on the target knee at any time.
7) Knee surgery on the target knee within the past 10 years (procedures such as
micro-perforation or cartilage repair).
8) Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000/µL.
9) Iodine allergy resulting in anaphylaxis.
10) Renal dysfunction as defined by GFR (eGFR) of <45 mL/min/1.73m2 obtained
within the past 60 days.
11) Ligament ruptures.
12) Contraindications for MR Imaging (such as claustrophobia, metallic fragment
or foreign bodies implants, or prosthesis).
13) Dementia.
14) Pregnancy or breastfeeding.
15) Gelatin allery resulting immun reaction.
16) Other cases where participation in this clinical trial is judged
inappropriate according to the judgment of the investigator.
17) No *Blush* is seen on the angiography and who do not experience *Pain* in
the area concerned.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85909.000.24 |