Trial Outcomes & Findings for Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial) (NCT NCT05705544)
NCT ID: NCT05705544
Last Updated: 2025-04-24
Results Overview
Diagnostic yield is defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion. The following common histopathological findings are pre-specified as lesional: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL 1. organizing pneumonia, or 2. frank purulence/robust neutrophilic inflammation, or 3. granulomatous inflammation, or 4. other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
447 participants
Primary outcome timeframe
7 days post-enrollment
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
Participants in the Ion™ Endoluminal System arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
203
|
|
Overall Study
COMPLETED
|
208
|
203
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial)
Baseline characteristics by cohort
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
n=208 Participants
Participants in the Electromagnetic navigational bronchoscopy (ENB) arm underwent a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
ILLUMISITE™ Platform (EMN bronchoscopy): Providers utilized the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
n=203 Participants
Participants in the Robotic assisted bronchoscopy (RAB) arm underwent a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Ion™ Endoluminal System (SSCB bronchoscopy): Providers utilized the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
69.0 years
n=7 Participants
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
189 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or unable to report
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
202 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
208 participants
n=5 Participants
|
203 participants
n=7 Participants
|
411 participants
n=5 Participants
|
|
Current malignancy
|
42 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Prior malignancy
|
73 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Body Mass Index, median
|
26.8 Kg/m^2
n=5 Participants
|
26.5 Kg/m^2
n=7 Participants
|
26.6 Kg/m^2
n=5 Participants
|
|
Anticoagulation or antiplatelet
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Smoking history
Current
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Smoking history
Former
|
94 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Smoking history
Never
|
70 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Lesion size, largest diameter (mm), median
|
20.0 mm
n=5 Participants
|
18.0 mm
n=7 Participants
|
19.0 mm
n=5 Participants
|
|
Lesion location (outer 1/3 of the chest)
|
141 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Lesion density (solid)
|
176 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Lesion spiculation
|
41 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Bronchus sign present
|
128 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Lesion distance from pleura (mm), median
|
4.0 mm
n=5 Participants
|
6.0 mm
n=7 Participants
|
5.0 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-enrollmentDiagnostic yield is defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion. The following common histopathological findings are pre-specified as lesional: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL 1. organizing pneumonia, or 2. frank purulence/robust neutrophilic inflammation, or 3. granulomatous inflammation, or 4. other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns.
Outcome measures
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
n=208 Participants
Participants in the Electromagnetic navigational bronchoscopy (ENB) arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
ILLUMISITE™ Platform (EMN bronchoscopy): Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
n=203 Participants
Participants in the Robotic assisted bronchoscopy (RAB) arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Ion™ Endoluminal System (SSCB bronchoscopy): Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
|
|---|---|---|
|
Diagnostic Yield
|
157 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Duration of procedure, approximately 60 minutesDefined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures
Outcome measures
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
n=208 Participants
Participants in the Electromagnetic navigational bronchoscopy (ENB) arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
ILLUMISITE™ Platform (EMN bronchoscopy): Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
n=203 Participants
Participants in the Robotic assisted bronchoscopy (RAB) arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Ion™ Endoluminal System (SSCB bronchoscopy): Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
|
|---|---|---|
|
Duration of Procedure
|
32.0 minutes
Interval 25.0 to 43.3
|
37.0 minutes
Interval 29.0 to 48.0
|
Adverse Events
ILLUMISITE™ Platform (EMN Bronchoscopy)
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Ion™ Endoluminal System (SSCB Bronchoscopy)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
n=208 participants at risk
Participants in the Electromagnetic navigational bronchoscopy (ENB) arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
ILLUMISITE™ Platform (EMN bronchoscopy): Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
n=203 participants at risk
Participants in the Robotic assisted bronchoscopy (RAB) arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Ion™ Endoluminal System (SSCB bronchoscopy): Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
6/208 • 7 days
|
2.0%
4/203 • 7 days
|
|
Injury, poisoning and procedural complications
Anesthesia Complication
|
0.48%
1/208 • 7 days
|
0.49%
1/203 • 7 days
|
Other adverse events
| Measure |
ILLUMISITE™ Platform (EMN Bronchoscopy)
n=208 participants at risk
Participants in the Electromagnetic navigational bronchoscopy (ENB) arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
ILLUMISITE™ Platform (EMN bronchoscopy): Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
|
Ion™ Endoluminal System (SSCB Bronchoscopy)
n=203 participants at risk
Participants in the Robotic assisted bronchoscopy (RAB) arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Ion™ Endoluminal System (SSCB bronchoscopy): Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.48%
1/208 • 7 days
|
0.00%
0/203 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.48%
1/208 • 7 days
|
0.00%
0/203 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Persistent dyspnea post-procedure
|
0.96%
2/208 • 7 days
|
0.00%
0/203 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Persistent Cough
|
0.48%
1/208 • 7 days
|
0.00%
0/203 • 7 days
|
Additional Information
Dr. Fabian Maldonado
Vanderbilt University Medical Center
Phone: (615) 322-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place