Lung DiseasesNCT06373224
Cold Saline Irrigation Before Endobronchial Biopsy
A study testing Flush in people with Lung Diseases, run by TriHealth Inc. at 1 site in United States.
Trial summary
Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Flush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital
Who cannot join
- Under 18 years old
- Does not speak English
- Unable to consent to involvement in the research study
- Is pregnant
- Has a bleeding disorder/diagnosis
- Currently taking anticoagulant medications and not stopped for procedure
- Documented low platelets (<100,000)
- Had a biopsy taken immediately prior to the endobronchial ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Preventive Cold Saline to Decrease Bleeding Associated With Endobronchial Biopsy
Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.
- Conditions
- Lung Diseases
- Being tested
- Flush
- Keywords
- Biopsy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlushOther
After identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope.
| Study group | Role | What they receive |
|---|---|---|
| Flush Group | Experimental | After identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope. Receives: Other: Flush |
| Standard Care Group | No intervention | No irrigation before the biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unreadable Biopsy Slides
cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide
Measured: from enrollment until discharge from biopsy appointment, up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Dec 2023
- Primary completion23 May 2025
- Study completion30 Dec 2025
Why it stopped: Unable to enroll enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Pittman, BSN, RN, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373224
- Sponsor's protocol ID
- 23-037
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2023
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Preventive Cold Saline to Decrease Bleeding Associated With Endobronchial Biopsy
- ClinicalTrials.gov ID
- NCT06373224
- Acronym / sponsor ID
- 23-037
- Conditions
- Lung Diseases
- Keywords
- Biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll enough participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Posted 2 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flush Group | Experimental | Other: FlushAfter identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope. |
| Standard Care Group | No intervention | –No irrigation before the biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital
Key exclusion criteria (8 listed)
- Under 18 years old
- Does not speak English
- Unable to consent to involvement in the research study
- Is pregnant
- Has a bleeding disorder/diagnosis
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 |
|---|---|---|
| FlushAfter identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope. | Other | Flush Group |
Primary outcome
Unreadable Biopsy Slides
Time frame: from enrollment until discharge from biopsy appointment, up to 12 hours
cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Austin Pittman, BSN, RN principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flush in people with Lung Diseases, run by TriHealth Inc. at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 2 Apr 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unreadable Biopsy Slides (time frame: from enrollment until discharge from biopsy appointment, up to 12 hours). 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 Apr 2026.