Archive for Clinical

Allegheny Health Network Among 15 Centers Nationwide Launching Clinical Trial of Non-Surgical Weight Loss Balloon


PITTSBURGH, PA (PRWEB) April 24, 2015

Allegheny Health Network today announced its participation in the first U.S. clinical trial evaluating the effectiveness of a non-surgical alternative, the Obalon Balloon, in helping people lose weight.

A team led by George M. Eid, MD, FACS, FASMBS, System Division Chief, Minimally Invasive Surgery, and System Director, Bariatric and Metabolic Institute, will examine whether the Obalon Balloon, which is placed when the patient swallows an inflatable capsule, can help people who have struggled to lose weight with diet and exercise.

“Many patients need help losing weight but are not interested in, or don’t qualify for, bariatric surgery,” Dr. Eid said. “The Obalon Balloon could offer an alternative that is discreet, non-surgical and reversible, leading to progressive weight loss over a six-month period.”

With the progressive Obalon approach, a total of three balloons are placed over several weeks. The patient swallows the capsule containing the balloon, then it is inflated with gas. The balloon is designed to occupy space in the stomach so that the patient feels fuller and eats less. After six months, the balloons are removed in an outpatient procedure, using a flexible tube/camera that is inserted into the mouth.

Participants in the study will be randomized into two groups; one will receive the Obalon Balloon, the other, a sham device. All patients will receive diet and exercise counseling. After six months, the balloons will be removed and patients will be told if they received the balloon or a sham.

Patients who received the balloon will then begin a second six-month weight loss session without the balloons, continuing to visit their doctor’s office for diet and exercise counseling. Those who did not receive the balloon but still qualify for the study, will have the option to receive the Obalon Balloon at no cost.

The Obalon Balloon is not currently commercially available in the U.S., but is approved in some European countries.

To qualify, patients must be 22 to 64 years old, have a Body Mass Index between 30 and 40, not have had or be considering bariatric surgery, and able to attend regular appointments over a one-year period.

For more information, call 1-855-878-8390 or visit http://www.BalloonTrial.com

About the Allegheny Health Network:

Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.







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PuraCath Medical Presents Study at National Kidney Foundation 2015 Spring Clinical Meetings


Dallas, Texas (PRWEB) March 27, 2015

PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it presented new scientific data on its proprietary ultraviolet light-based technology during the National Kidney Foundation’s (NKF) 2015 Spring Clinical Meetings. The study presented reported on the ability to reduce bacterial growth in a simulated peritoneal dialysis delivery system when combining ultraviolet (UV) light with a UV transmissible connection system. This data confirms the effectiveness of combining UV light with a UV transmissible connection system to reduce bacterial growth across a wider range of bacteria and a fungi (Candida albicans) which are known to contribute to infections and peritonitis in peritoneal dialysis patients. The current study builds on earlier research the company presented at the American Society of Nephrology meeting in 2014.

“PuraCath Medical’s technology is a revolutionary approach to reducing the risk of infections that could lead to a change in the way peritoneal dialysis is performed,” stated Alberto Sabucedo, M.D., Ph.D., from the Department of Nephrology and Hypertension at the University of Miami. “This is a promising technology that will enable a better quality of life for patients on peritoneal dialysis, and I look forward to utilizing in my practice when it is available for clinical use.”

“While there is increasing interest in the use of peritoneal dialysis therapy to manage patients with end-stage renal disease, patients still currently remain at risk of developing infections and peritonitis from low compliance with rigorous disinfection protocols, impacting their ability to remain on this therapy for the long term,” said Julia Rasooly, PuraCath Medical’s CEO. “The study we presented at the NKF meeting confirms that our approach to reduce bacterial growth through the use of a novel UV light-based PD purification system is effective across a wider range of microorganisms than we initially tested. Based on the results of this study and the rapid progress we have made with our product development efforts to date, we look to initiate the first clinical studies of our technology in PD patients in the near future. PuraCath believes in the value and the lifestyle convenience peritoneal dialysis therapy offers to patients and we are developing a PD disinfection system that enhances PD patient’s quality of life and also provides an easy-to-use, patient friendly option to reducing bacterial and fungal contamination during PD exchanges. We feel confident that this will allow a broader range of patients to benefit from the quality of life of treatment on PD.”

WHAT IS PERITONEAL DIALYSIS?

Peritoneal dialysis is a home-based dialysis therapy that offers patients a more flexible and physiologically smoother dialysis option. Unlike hemodialysis, peritoneal dialysis uses a patient’s peritoneal membrane to remove toxins and excess fluid from a patient. Peritoneal dialysis therapy permits patients to have a more regular diet and more flexible treatment times, improving their quality of life. Currently there are over 45,000 peritoneal dialysis patients in the U.S. with the number of patients on this therapy increasing over the past several years. The most common complications from peritoneal dialysis include infection around the catheter site or infection of the lining of the abdominal wall (peritonitis).

ABOUT PURACATH MEDICAL

PuraCath Medical is a company based in San Francisco, CA and is dedicated to improving the quality of life for the dialysis patient by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connection of PD catheters. The Company utilizes technology that was spun out of Stanford University and is developing a novel, easy-to-use technology designed to reduce the risk of infections in patients with intravascular and peritoneal catheters in order to decrease infection-related hospitalizations and their associated costs.

For more information on PuraCath Medical, please visit http://www.puracath.com.