Madela THOPAZ Suction Pump for Air Leak

University of Oklahoma, Oklahoma City, OK
Air LeakMadela THOPAZ Digital Device - Device
Eligibility
No minimum age - 17
All Sexes

Study Summary

This trial is looking at whether using a digital chest tube drainage system instead of an analog one has benefits for pediatric patients.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Madela THOPAZ Suction Pump
1 of 2
Atrium Dry Suction Control Water Seal Chest Drain
1 of 2

Active Control

140 Total Participants · 2 Treatment Groups

Primary Treatment: Madela THOPAZ Suction Pump · No Placebo Group · Phase < 1

Madela THOPAZ Suction Pump
Device
ActiveComparator Group · 1 Intervention: Madela THOPAZ Digital Device · Intervention Types: Device
Atrium Dry Suction Control Water Seal Chest Drain
Device
ActiveComparator Group · 1 Intervention: Atrium Analog Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

University of OklahomaLead Sponsor
434 Previous Clinical Trials
99,343 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 17 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Does this research endeavor accept participants who are 18 years of age or older?

"This research is targeting participants between the ages of 0 minutes and 17 years old." - Anonymous Online Contributor

Unverified Answer

How many participants are permitted to take part in this medical trial?

"Affirmative. Clinicaltrials.gov has the most up-to-date information, which indicates that this medical trial posted on August 15th 2022 is actively recruiting patients. 140 individuals will be accepted from a single site for study participation." - Anonymous Online Contributor

Unverified Answer

Am I suitable to participate in this experiment?

"For this medical trial, 140 participants between 0 minutes and 17 years old with air leakage must be recruited. In addition to the age requirement, all candidates must have undergone chest tube placement for spontaneous pneumothorax or pulmonary resection at The Children's Hospital by a surgeon (or in training)." - Anonymous Online Contributor

Unverified Answer

Are volunteers currently being accepted for this experiment?

"Affirmative, the information hosted on clinicaltrials.gov affirms that this trial is actively looking for participants. Initially posted on August 15th 2022 and most recently modified on August 19th 2022, the experiment seeks to recruit 140 individuals from 1 medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.