Gastric Bypass SurgeryNCT03402347
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
A study testing Non-ionising radiation in people with Gastric Bypass Surgery, run by RSP Systems A/S at 1 site in Denmark.
Trial summary
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Bypass Surgery
- What is being tested?
- Non-ionising radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 16 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subject 18 years of age or older
- Gastric bypass operated or similar
- Excess abdominal skin to be removed surgically
- Abdominal skin tone 4 or below
Who cannot join
- Extensive skin changes, tattoos or diseases on skin explant to be donated
- Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.
Read the detailed description
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.
- Conditions
- Gastric Bypass Surgery
- Being tested
- Non-ionising radiation
- Keywords
- Ex vivo, Gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ionising radiationRadiation
Laser regimes will be applied to ex vivo skin samples.
| Study group | Role | What they receive |
|---|---|---|
| Laser irradiation regimes | Experimental | Non-ionising radiation intervention will be applied to skin explants Receives: Radiation: Non-ionising radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal damage threshold
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.
Measured: Within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Jan 2019
- Primary completion16 Jun 2019
- Study completion16 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass SurgeryStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Excess skin from corrective surgery will be evaluated ex vivo.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSP Systems A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Ahm Sørensen, MD, Principal investigator, Department of plastic surgery Z OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402347
- Sponsor's protocol ID
- RSP-11
- Status last verified
- Jul 2019
- First submitted
- 10 Jan 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
- ClinicalTrials.gov ID
- NCT03402347
- Acronym / sponsor ID
- RSP-11
- Conditions
- Gastric Bypass Surgery
- Keywords
- Ex vivo, Gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- RSP Systems A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 16 Jun 2019 (actual)
- First posted
- 18 Jan 2018 (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.
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.
Detailed description
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Excess skin from corrective surgery will be evaluated ex vivo.
| Arm | Type | Receives |
|---|---|---|
| Laser irradiation regimes | Experimental | Radiation: Non-ionising radiationNon-ionising radiation intervention will be applied to skin explants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subject 18 years of age or older
- Gastric bypass operated or similar
- Excess abdominal skin to be removed surgically
- Abdominal skin tone 4 or below
Key exclusion criteria (2 listed)
- Extensive skin changes, tattoos or diseases on skin explant to be donated
- Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.
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 |
|---|---|---|
| Non-ionising radiationLaser regimes will be applied to ex vivo skin samples. | Radiation | Laser irradiation regimes |
Primary outcome
Thermal damage threshold
Time frame: Within 3 months
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.
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 2 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Jens Ahm Sørensen, MD principal investigator
Department of plastic surgery Z OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ionising radiation in people with Gastric Bypass Surgery, run by RSP Systems A/S at 1 site in Denmark.
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 4 inclusion and 2 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 2 Jul 2019. 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 Denmark. 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. 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?
Thermal damage threshold (time frame: Within 3 months). 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 2 Jul 2019.