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RecruitingNCT07730931Updated Jul 28, 2026

Forced Oscillatory Technique for Bronchiolitis Obliterans Syndrome After Allogeneic Bone Marrow Transplantation

An interventional study of FOT - Forced Oscillation Technique in Bronchiolitis Obliterable Syndrome, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Aug 2021, registered Jul 2026).
  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
6 Months and older
Sex
All
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Study summary

Bronchiolitis obliterans syndrome (BOS) is a severe pulmonary complication following allogeneic hematopoietic stem cell transplantation (HSCT). This prospective study evaluates the usefulness of the Forced Oscillation Technique (FOT) for the diagnosis, early detection, monitoring, and assessment of treatment response in patients undergoing allogeneic HSCT. FOT results will be compared with standard pulmonary function tests (spirometry, lung volumes, and DLCO).

Read the detailed description

This prospective study conducted at Hadassah Medical Organization. Patients aged 6 months and older undergoing allogeneic hematopoietic stem cell transplantation who are referred for pulmonary function testing will be enrolled. Participants will undergo standard pulmonary function tests according to routine clinical practice, including spirometry, static lung volumes, and DLCO, together with Forced Oscillation Technique (FOT). Clinical characteristics, transplant characteristics, pulmonary symptoms, graft-versus-host disease status, imaging findings, treatments, and pulmonary function parameters will be collected prospectively. Participants will be followed for up to three years to evaluate the role of FOT in the diagnosis, monitoring, and assessment of bronchiolitis obliterans syndrome and small airway disease following HSCT

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Conditions studied

  • Bronchiolitis Obliterable Syndrome

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Keywords

  • FOT
  • BOS
  • Bronchiolitis Obliterable Syndrome
  • Forced Oscillation Technique
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In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All patients age 6 months and above, undergoing HSCT, referred for pulmonary function test evaluation at the Hadassah Ein Kerem Institute of Pulmonary Medicine .
  2. Ability to provide for performing FOT and database enrollment by patient or legal guardians.

Exclusion criteria

Exclusion Criteria:

1. Inability or unwillingness to perform FOT

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    FOT Assessment

    Diagnostic Test: FOT - Forced Oscillation Technique

Interventions

  • Diagnostic testFOT - Forced Oscillation Technique

    Forced Oscillation Technique (FOT) performed in addition to standard pulmonary function testing for the assessment of bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation

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What researchers measure

Primary outcomes

  1. Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)

    Diagnostic accuracy of FOT for early detection of BOS, assessed by sensitivity, specificity, and comparison with standard pulmonary function tests.

    Time frame: From allogeneic HSCT to 3 years after transplantation

  2. Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults

    Correlation between standard pulmonary function tests parameters (spirometry, static lung volumes and DLCO) and Forced Oscillatory Technique (FOT) measurements in patients with or without BOS following allogeneic HSCT in children and adults

    Time frame: From allogeneic HSCT to 3 years after transplantation

  3. Prevalence of small airway disease detected by FOT

    Prevalence of small airway disease detected by FOT following allogeneic HSCT, specifically in pediatric and adult patients with normal spirometry

    Time frame: From allogeneic HSCT to 3 years after transplantation

  4. FOT measurements during follow-up and response to medical treatment

    4\. Changes in FOT measurements during follow up and response to medical treatment in these patients

    Time frame: From allogeneic HSCT to 3 years after transplantation

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Dec 2028, 88 months after the start.

Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 88 months is above that.

Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 28, 2026
StartActual
Aug 19, 2021
Primary completionEst.
Dec 30, 2028
CompletionEst.
Dec 30, 2030
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07730931
Responsible party
Rotem Kuint (Principal Investigator Doctor KUINT ROTEM, Institute of Pulmonary Medicine, Hadassah Medical Organization) — Principal investigator
First posted
Jul 28, 2026
Start date
Aug 19, 2021
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Jul 28, 2026

Study contacts

Rottem Kuint, MD
Contact
KUINT@hadassah.org.il
+972532207609

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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