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Trial Outcomes & Findings for Evaluation of the Bio-Seal Biopsy Track Plug (NCT NCT00527722)

NCT ID: NCT00527722

Last Updated: 2012-08-07

Results Overview

Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

77 participants

Primary outcome timeframe

X-Rays at 0-60 minutes, 24 hours and 30 days

Results posted on

2012-08-07

Participant Flow

Recruitment Period: September 12, 2005 to February 21, 2008. All recruitment done at UT MD Anderson Cancer Center.

Participants who met the eligibility criteria (77 participants) were consented into study while another set of criteria had to be met for randomization. Only 47 participants met the randomization criteria.

Participant milestones

Participant milestones
Measure
Pleural Plug
Experimental lung plug after the lung biopsy.
No Pleural Plug
The standard lung biopsy without placement of the plug.
Overall Study
STARTED
22
25
Overall Study
COMPLETED
22
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Bio-Seal Biopsy Track Plug

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pleural Plug
n=22 Participants
Experimental lung plug after the lung biopsy.
No Pleural Plug
n=25 Participants
The standard lung biopsy without placement of the plug.
Total
n=47 Participants
Total of all reporting groups
Age Continuous
45 years
n=5 Participants
35 years
n=7 Participants
45 years
n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
16 Participants
n=7 Participants
28 Participants
n=5 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
25 participants
n=7 Participants
47 participants
n=5 Participants

PRIMARY outcome

Timeframe: X-Rays at 0-60 minutes, 24 hours and 30 days

Population: Intent-to-treat (ITT) population of all subjects who were randomized.

Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).

Outcome measures

Outcome measures
Measure
Pleural Plug
n=22 Participants
Experimental lung plug after the lung biopsy.
No Pleural Plug
n=25 Participants
The standard lung biopsy without placement of the plug.
Number of Participants With Absence of Pneumothoraces
18 Participants
18 Participants

Adverse Events

Pleural Plug

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

No Pleural 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

Sanjay Gupta, MD

UT MD Anderson Cancer Center

Phone: 713-563-7341

Results disclosure agreements

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