CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Simple Aspiration +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02573285
NCT02573285N/ACompleted
CompareCT.gov

Simple Aspiration for Initial Management of Primary Spontaneous Pneumothorax in Children: A Multi-Center Pilot Study

University of Wisconsin, Madison·interventional·Posted Oct 9, 2015·Updated Dec 5, 2019

In Brief

A clinical study evaluating Simple Aspiration and Surgeon Preference for Spontaneous Pneumothorax. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The objective of this multi-center, non-randomized, prospective pilot study is to examine the rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple aspiration technique. In this study, eligible subjects diagnosed with PSP at eleven participating large children's hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be enrolled and offered a choice of management with either the simple aspiration protocol or management according to their surgeon's preference, which may include simple aspiration, chest tube placement, or rarely, an operation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpontaneous Pneumothorax
CountriesUnited States
CollaboratorsChildren's Hospital Medical Center, Cincinnati, Indiana University, Medical College of Wisconsin, Northwestern University, Nationwide Children's Hospital, University of Chicago, University of Louisville, University of Michigan, Washington University School of Medicine, Children's Mercy Hospital Kansas City

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartMar 10, 2016
Primary CompletionJun 4, 2018
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.7 years ago

Interventions

Simple Aspirationprocedure

Aspiration of pneumothorax with a small-bore catheter

Surgeon Preferenceprocedure

Any standard treatment option may be utilized for the treatment of the pneumothorax, including simple aspiration, chest tube placement, or an operation (VATS).