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Trial Outcomes & Findings for CBCT-Guided Navigational Bronchoscopy For Lung Nodules (NCT NCT04758403)

NCT ID: NCT04758403

Last Updated: 2024-11-19

Results Overview

The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2024-11-19

Participant Flow

Participant milestones

Participant milestones
Measure
Navigation Bronchoscopy ALONE
Patients undergoing navigational bronchoscopy alone (not with CBCT) for peripheral pulmonary nodules.
CBCT-GUIDED Navigation Bronchoscopy
This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules -Follow-Up Visits at Week 1, 4 and 12 Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice. Cone beam computed tomography (CBCT): Per Protocol
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Navigation Bronchoscopy ALONE
n=10 Participants
This research study involves a screening period, a procedure and follow up visits * Procedure Visit Navigation Bronchoscopy Alone * Follow-Up Visits at Week 1, 4 and 12 Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
CBCT-GUIDED Navigation Bronchoscopy
n=10 Participants
This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules -Follow-Up Visits at Week 1, 4 and 12 Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice. Cone beam computed tomography (CBCT): Per Protocol
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
76 years
n=5 Participants
79 years
n=7 Participants
78 years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
8 Participants
n=7 Participants
17 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Enrolled before trial termination but no data were collected.

The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled before trial termination but no data were collected.

To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months

Population: Enrolled before trial termination but no data were collected.

To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months

Population: Enrolled before trial termination but no data were collected.

To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.

Outcome measures

Outcome data not reported

Adverse Events

Navigation Bronchoscopy ALONE

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

CBCT-GUIDED Navigation Bronchoscopy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adnan Majid

BIDMC

Phone: 617-632-8386

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place