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NCT02837601 · ClinicalTrials.gov registry record · NA
Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
A NA study, sponsored by Akron Children's Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 102
- Enrollment target
NCT02837601: Clinical Trial NA study, sponsored by Akron Children's Hospital.
NCT02837601 is a NA study that has not yet begun recruiting, run by Akron Children's Hospital. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02837601, a NA study, has not yet begun recruiting, sponsored by Akron Children's Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
Study Summary
A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms: 1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or 2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.
Primary Outcome
Severity of shoulder pain, which will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
Interventions
- DEVICE AirSeal® Insufflation System (AIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2021-03 |
| Est. Completion | 2027-11 |
| Phase | NA |
What is known before NCT02837601 opens enrollment
NCT02837601 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which AirSeal® Insufflation System (AIS) is the first listed.
NCT02837601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02837601 about?
NCT02837601 is a clinical study titled "Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure". A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment devi...
What is the current status of trial NCT02837601?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2021-03. Estimated completion is 2027-11.
What interventions are being tested in trial NCT02837601?
The interventions under investigation include: AirSeal® Insufflation System (AIS) (DEVICE).
Who is sponsoring clinical trial NCT02837601?
This trial is sponsored by Akron Children's Hospital, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02837601's enrollment target sits among peer trials
102 837th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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