A Phase 3 interventional study of ABPI and BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug in Lung Biopsy, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.
178 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.
This study's enrollment of 454 is above the median of 100 across 115 interventional studies indexed under Pneumothorax.
Browse Pneumothorax studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Exclusion Criteria:
Other: ABPI
Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
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.
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
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.
Time frame: 2 hours post procedure
| Milestone | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug |
|---|---|---|
| Started | 226 | 228 |
| Completed | 156 | 162 |
| Not completed | 70 | 66 |
| Withdrew: Withdrawal by subject | 7 | 6 |
| Withdrew: Biopsy cancelled | 20 | 14 |
| Withdrew: Intra procedural exclusion - sealant deployed | 23 | 11 |
| Withdrew: Intra procedural exclusion - sealant not deployed | 20 | 35 |
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.
| Participants | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug |
|---|---|---|
| Experienced pneumothorax within 2 hours post procedure | 42 | 60 |
| Did not experience pneumothorax within 2 hours post procedure | 184 | 168 |
Collected over 2 weeks post procedure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Autologous Blood Patch Injection (ABPI) | 0/226 (0%) | 0/226 (0%) | 0/226 (0%) |
| BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | 0/228 (0%) | 0/228 (0%) | 0/228 (0%) |
| Age, Continuous(years) | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | Total |
|---|---|---|---|
| Mean | 66.8 (32 to 92) | 67 (24 to 93) | 67 (24 to 93) |
| Sex: Female, Male(Participants) | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | Total |
|---|---|---|---|
| Female | 124 | 127 | 251 |
| Male | 102 | 100 | 202 |
| Ethnicity (NIH/OMB)(Participants) | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 10 | 21 |
| Not Hispanic or Latino | 164 | 164 | 328 |
| Unknown or Not Reported | 51 | 53 | 104 |
| Race (NIH/OMB)(Participants) | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 13 | 12 | 25 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 11 | 10 | 21 |
| White | 188 | 190 | 378 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 12 | 15 | 27 |
| Region of Enrollment(Participants) | Autologous Blood Patch Injection (ABPI) | BioSentry (Formerly Known as Bio-Seal) Hydrogel Tract Plug | Total |
|---|---|---|---|
| United States | 226 | 227 | 453 |
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Memorial Sloan Kettering Cancer Center