Bronchus AnastomosisPILOT-Tx-HSINCT04784884
Hyperspectral Imaging in Thoracic Surgery
A study testing HSI in people with Bronchus Anastomosis and Bronchus Stump, run by LungenClinic Grosshansdorf at 1 site in Germany.
Trial summary
The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bronchus Anastomosis, Bronchus Stump, Tissue Oxygenation
- What is being tested?
- HSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jan 2021to 7 Apr 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung resection or other resection via thoracotomy
Who cannot join
- Restriction of the ability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Intraoperative Tissue Differentiation and Vascular Perfusion Using Intraoperative Hyperspectral Imaging (HSI) in Benign and Malignant Diseases of the Lung, Pleura and Mediastinum
The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.
Read the detailed description
The bronchus before lung resection and the bronchus stump or bronchus anastomosis, respectively, are investigated. The hyperspectral imaging camera head is placed and aligned over the surgical (camera and object distance: 30 cm for all measurements). The Field of view is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range from 500 to 1000 nm were applied. The software calculates the tissue oxygenation [%] , organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated tissue. The study was designed to investigate tissue oxygenation in the superficial (app. 1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.
- Conditions
- Bronchus Anastomosis, Bronchus Stump, Tissue Oxygenation
- Being tested
- HSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSIDevice
diagnostic hyperspectral imaging
| Study group | Role | What they receive |
|---|---|---|
| HSI-Pilot | Experimental | Diagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively Receives: Device: HSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation: Bronchus before lung resection
Tissue perfusion of the bronchus before lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood in superficial tissue layers (penetration depth: approx. 1 mm)
Measured: directly before lung resection
Oxygenation: Bronchus stump or bronchus anastomosis after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood the in superficial tissue layers (penetration depth: approx. 1 mm)
Measured: 10-15 minutes after lung resection
Near Infrared Perfusion Index: Bronchus before lung resection
Tissue perfusion of the bronchus before lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Measured: directly before lung resection
Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Measured: 10-15 minutes after lung resection
Tissue-Hemoglobin index: Bronchus before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
Measured: directly before lung resection
Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
Measured: 10-15 minutes after lung resection
Tissue-Water-Index: Bronchus before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Water-Index: Existing water distribution in the tissue
Measured: directly before lung resection
Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Water-Index: Existing water distribution in the tissue
Measured: 10-15 minutes after lung resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start21 Jan 2021
- Primary completion31 Mar 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchus AnastomosisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- LungenClinic Grosshansdorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B. Ellebrecht, MD, Principal investigator, LungenClinic Grosshansdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784884
- Sponsor's protocol ID
- PILOT-Tx-HSI
- Acronym
- PILOT-Tx-HSI
- Status last verified
- Apr 2021
- First submitted
- 25 Feb 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ellebrecht DB, Kugler C. Intraoperative Determination of Bronchus Stump and Anastomosis Perfusion with Hyperspectral Imaging. Surg Innov. 2023 Jun;30(3):314-323. doi: 10.1177/15533506231157165. Epub 2023 Feb 21.
PubMed 36802983
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Intraoperative Tissue Differentiation and Vascular Perfusion Using Intraoperative Hyperspectral Imaging (HSI) in Benign and Malignant Diseases of the Lung, Pleura and Mediastinum
- ClinicalTrials.gov ID
- NCT04784884
- Acronym / sponsor ID
- PILOT-Tx-HSI / PILOT-Tx-HSI
- Conditions
- Bronchus Anastomosis, Bronchus Stump, Tissue Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- LungenClinic GrosshansdorfUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 5 Mar 2021 (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 aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.
Detailed description
The bronchus before lung resection and the bronchus stump or bronchus anastomosis, respectively, are investigated. The hyperspectral imaging camera head is placed and aligned over the surgical (camera and object distance: 30 cm for all measurements). The Field of view is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range from 500 to 1000 nm were applied. The software calculates the tissue oxygenation [%] , organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated tissue. The study was designed to investigate tissue oxygenation in the superficial (app. 1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSI-Pilot | Experimental | Device: HSIDiagnostic hyperspectral imaging of the bronchus stump or bronchus anastomosis after lung resection and calculating the stump or anastomotic Perfusion measures, respectively |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lung resection or other resection via thoracotomy
Key exclusion criteria (1 listed)
- Restriction of the ability to consent
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 |
|---|---|---|
| HSIdiagnostic hyperspectral imaging | Device | HSI-Pilot |
Primary outcome
Oxygenation: Bronchus before lung resection
Time frame: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood in superficial tissue layers (penetration depth: approx. 1 mm)
Oxygenation: Bronchus stump or bronchus anastomosis after lung resection
Time frame: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood the in superficial tissue layers (penetration depth: approx. 1 mm)
Near Infrared Perfusion Index: Bronchus before lung resection
Time frame: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection
Time frame: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Tissue-Hemoglobin index: Bronchus before lung resection
Time frame: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection
Time frame: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
Tissue-Water-Index: Bronchus before lung resection
Time frame: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Water-Index: Existing water distribution in the tissue
Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection
Time frame: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Water-Index: Existing water distribution in the tissue
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 Jun 2022.
- Derived from this study: PubMed 36802983Ellebrecht DB, Kugler C. Intraoperative Determination of Bronchus Stump and Anastomosis Perfusion with Hyperspectral Imaging. Surg Innov. 2023 Jun;30(3):314-323. doi: 10.1177/15533506231157165. Epub 2023 Feb 21.
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.
David B. Ellebrecht, MD principal investigator
LungenClinic Grosshansdorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSI in people with Bronchus Anastomosis and Bronchus Stump, run by LungenClinic Grosshansdorf at 1 site in Germany.
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 Jun 2022. 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 Germany. 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?
Oxygenation: Bronchus before lung resection (time frame: directly before lung resection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784884, which also lists 1 linked publication.
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 Jun 2022.