OsteosarcomaESWTNCT05801887
Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
A study testing Extracorporeal shockwave device and No ESWT in people with Osteosarcoma, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Extracorporeal shockwave device and No ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 22 Oct 2021to 6 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cell cultures with a confluency of 70%-80%
Who cannot join
- Contaminated cell cultures
Trial locations and contacts
1 site in 1 country.
About this study
The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. The present study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability. It will be assessed using a scratch assay, Mtt assay and ATP analysis.
Read the detailed description
Introduction:
Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis.
Aim:
This study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability.
Methodology:
In this in-vitro study, 20 Osteoblast - like cells will be included. 10 samples to be considered for Control group and the remaining 10 samples considered as Test group. Extracorporeal shockwave will be applied to the Test samples. They will be further analysed using wound scratch assay which is used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay used to determine Cell viability after exposure to shockwaves. The cell migration and cell viability after exposure to shockwaves will determine its effects on osteoblast-like cells.
- Conditions
- Osteosarcoma
- Being tested
- Extracorporeal shockwave device, No ESWT
- Keywords
- ESWT, Cell proliferation, Cell viability
- Medical subject headings
- Osteosarcoma, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave deviceDevice
Also called ESWT
Extracorporeal shockwave device generates true shock waves which are characterized by a sudden rise in pressure followed by an exponential decay.
This is different from the commercially available shockwave devices in which they use piezoelectric based mechanisms which generate high frequency waves.
No ESWTDevice
Also called shockwave
the osteoblast like cells are not exposed to shockwaves
| Study group | Role | What they receive |
|---|---|---|
| Shockwave treated group | Experimental | The osteoblast like cells are treated with shockwaves Receives: Device: Extracorporeal shockwave device |
| No shockwave group | Placebo comparator | The osteoblast like cells are not exposed to shockwaves Receives: Device: No ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scratch assay
cell migration
Measured: 72hours
MTT Assay and ATP analysis
Cell viability
Measured: 74hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start22 Oct 2021
- Primary completion17 Aug 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- test group - application of shockwave on osteoblast control group - No shockwave on osteoblast
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801887
- Sponsor's protocol ID
- 02_D012_112292
- Acronym
- ESWT
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
- ClinicalTrials.gov ID
- NCT05801887
- Acronym / sponsor ID
- ESWT / 02_D012_112292
- Conditions
- Osteosarcoma
- Keywords
- ESWT, Cell proliferation, Cell viability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. The present study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability. It will be assessed using a scratch assay, Mtt assay and ATP analysis.
Detailed description
Introduction:
Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis.
Aim:
This study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability.
Methodology:
In this in-vitro study, 20 Osteoblast - like cells will be included. 10 samples to be considered for Control group and the remaining 10 samples considered as Test group. Extracorporeal shockwave will be applied to the Test samples. They will be further analysed using wound scratch assay which is used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay used to determine Cell viability after exposure to shockwaves. The cell migration and cell viability after exposure to shockwaves will determine its effects on osteoblast-like cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- test group - application of shockwave on osteoblast control group - No shockwave on osteoblast
| Arm | Type | Receives |
|---|---|---|
| Shockwave treated group | Experimental | Device: Extracorporeal shockwave deviceThe osteoblast like cells are treated with shockwaves |
| No shockwave group | Placebo comparator | Device: No ESWTThe osteoblast like cells are not exposed to shockwaves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cell cultures with a confluency of 70%-80%
Key exclusion criteria (1 listed)
- Contaminated cell cultures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwave deviceAlso: ESWTExtracorporeal shockwave device generates true shock waves which are characterized by a sudden rise in pressure followed by an exponential decay. This is different from the commercially available shockwave devices in which they use piezoelectric based mechanisms which generate high frequency waves. | Device | Shockwave treated group |
| No ESWTAlso: shockwavethe osteoblast like cells are not exposed to shockwaves | Device | No shockwave group |
Primary outcome
Scratch assay
Time frame: 72hours
cell migration
MTT Assay and ATP analysis
Time frame: 74hrs
Cell viability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave device and No ESWT in people with Osteosarcoma, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scratch assay (time frame: 72hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.