Trial Outcomes & Findings for Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures (NCT NCT02224924)
NCT ID: NCT02224924
Last Updated: 2024-01-30
Results Overview
within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
2 hours post procedure
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Autologous Blood Patch Injection (ABPI)
ABPI: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
|
BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug: If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
228
|
|
Overall Study
COMPLETED
|
156
|
162
|
|
Overall Study
NOT COMPLETED
|
70
|
66
|
Reasons for withdrawal
| Measure |
Autologous Blood Patch Injection (ABPI)
ABPI: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
|
BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug: If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Biopsy cancelled
|
20
|
14
|
|
Overall Study
Intra procedural exclusion - sealant deployed
|
23
|
11
|
|
Overall Study
Intra procedural exclusion - sealant not deployed
|
20
|
35
|
Baseline Characteristics
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Baseline characteristics by cohort
| Measure |
Autologous Blood Patch Injection (ABPI)
n=226 Participants
ABPI: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
|
BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug
n=227 Participants
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug: If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
378 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
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
226 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post procedurewithin 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
Outcome measures
| Measure |
Autologous Blood Patch Injection (ABPI)
n=226 Participants
ABPI: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
|
BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug
n=228 Participants
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug: If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
|
|---|---|---|
|
the Rate of Pneumothorax
Experienced pneumothorax within 2 hours post procedure
|
42 Participants
|
60 Participants
|
|
the Rate of Pneumothorax
Did not experience pneumothorax within 2 hours post procedure
|
184 Participants
|
168 Participants
|
Adverse Events
Autologous Blood Patch Injection (ABPI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug
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
Dr. Amgad Moussa MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place