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This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
XprESS Balloon Device
Texas Sinus Center
Entellus Medical, Inc.
Published on BioPortfolio: 2010-07-15T17:00:00-0400
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this ...
This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation proced...
This study was taken out to compare two mechanical devices (intrauterine balloon and intrauterine contraceptive device) in the therapy for intrauterine adhesions after hysteroscopic adhesi...
The purpose of this study is to learn more about the genetics of chronic sinusitis and identify genes involved in chronic sinusitis.
Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious diseases of the upper respiratory tract. Its treatment is limited and may be due largely in part to...
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are iden...
The Inoue balloon technique is the standard technique for mitral valve balloon commissurotomy at this stage. However, the hardware for this technique is expensive and may not always be available in re...
Objective The rate of balloon dilator failure is unknown, and a rescue strategy for device malfunction has not been established. The purposes of this investigation were to determine the approximate nu...
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a percutaneous transfemoral balloon technique used in select centers for resuscitation and temporary hemostasis, often instead of e...
Developing soft devices for invasive procedures bears great importance for human health. The softness and large strain actuation of responsive hydrogels promise the potential to fabricate soft devices...
An inflatable device implanted in the stomach as an adjunct to therapy of morbid obesity. Specific types include the silicone Garren-Edwards Gastric Bubble (GEGB), approved by the FDA in 1985, and the Ballobes Balloon.
Inflammation of the NASAL MUCOSA in the SPHENOID SINUS. Isolated sphenoid sinusitis is uncommon. It usually occurs in conjunction with other paranasal sinusitis.
The use of balloon CATHETERS to remove emboli by retraction of the balloon that is inflated behind the EMBOLUS.
A balloon-assisted enteroscopy utilizing a flexible endoscope with one overtube balloon control unit.
Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.