>>> ACCORDING TO THE C.D.C., MORE THAN ONE-THIRD OF ADULTS IN
AMERICA ARE OBESE.
AND OBESITY BRINGS WITH IT OTHER HEALTH PROBLEMS, INCLUDING
DIABETES, HEART DISEASE, AND SOME TYPES OF CANCER.
THERE IS A NEW CLINICAL TRIAL REGULATED BY THE F.D.A.
AT HOLYOKE MEDICAL CENTER TESTING
THE ELIPSE BALLOON, A NONSURGICAL METHOD TO HELP
PEOPLE STRUGGLING TO LOSE WEIGHT.
CAROLEE MCGRATH SAT DOWN WITH DR.
YANNIS RAFTOPOLOS, THE DIRECTOR OF HOLYOKE MEDICAL
CENTER'S WEIGHT MANAGEMENT PROGRAM TO LEARN MORE.
>> THIS IS -- WE'RE THE ONLY HOSPITAL IN THE
NORTHEAST INVOLVED IN IT AND I'M EXCITED ABOUT THIS STUDY BECAUSE
I HAD THE EXPERIENCE AND THE OPPORTUNITY TO WORK WITH IN
EUROPE, I WAS PART OF THE EUROPEAN TRIAL.
AND NOW WE HAVE THE OPPORTUNITY TO DO THE SAME THING IN THE
U.S., AND HOPEFULLY THE DEVICE WILL PASS AND BE AVAILABLE IN
THE U.S., HOPEFULLY THE NEXT TWO OR THREE YEARS.
THERE'S NOTHING NECESSARY THE WEIGHT LOSS FIELD THAT YOU CAN
PRODUCE WITHOUT SOME KIND OF INTERVENTION, SEDATION AND
ANESTHESIA AND SURGERY.
THIS IS THE ONLY THING AVAILABLE TO MY
KNOWLEDGE, SO IT'S PRETTY EXCITING.
>> NO SURGERY?
>> NO SURGERY, NO ANESTHESIA, NO EN DOSCOPY, NOTHING.
THIS IS THE CAPSULE.
YOU NEED THE CATHETER TO EVENTUALLY INFLATE THE CAPSULE
TO BECOME A FULL BALLOON, AND YOU NEED THE CATHETER TO INSTILL
THE FLUID INTO THE CAPSULE.
SO THE PATIENT HAS TO SWALLOW THE
CAPSULE ORIGINALLY WITH PART OF THIS CATHETER.
THE OTHER END OF THE CATHETER STAYS OUT OF THE MOUTH SO WE CAN
USE IT TO CONNECT THE FLUID AND FILL THE CAPSULE.
IT'S NOT, AS YOU CAN SEE, IT'S A SIZABLE CAPSULE, BUT IT CAN BE
SWALLOWED.
AND MY EXPERIENCE WITH SOME PRACTICE AND TRAINING THAT MOST
PATIENTS CAN DO IT.
WE ALSO HAVE A PRACTICE CAPSULE WHERE THE PATIENTS CAN PRACTICE
WITH AT THE OFFICE AND THAT HELPS.
SO THE PROCESS TAKES PLACE IN THE RADIOLOGY DEPARTMENT BECAUSE
WE NEED TO CONFIRM BY X RAY WHERE THE CAPSULE IS BEFORE WE
INFLATE IT.
SO THE PATIENT SIMPLY INGESTS THE CAPSULE WITH WATER, IT GOES
INTO THE STOMACH, TAKES ABOUT THREE OR FOUR MINUTES TO DO
THAT.
ONCE CONFIRMED BY X RAY THAT IT'S IN THE STOMACH, THEN WE
CONNECT THE OTHER END TO THE FLUID.
WE FILL THE CAPSULE WITH ABOUT 500CC'S OF FLUID AND THEN IT
BECOMES THIS BALLOON.
>> AND THAT STAYS IN THEIR STOMACH?
>> CORRECT.
ONCE IT'S FULLY FILLED WE DO ANOTHER X RAY TO CONFIRM THAT
EVERYTHING IS FINE AND THEN WITH A SIMPLE PULL, WE DETACH THE
CATHETER FROM THE ACTUAL BALLOON, THEN THE BALLOON STAYS
IN THE STOMACH FOR ABOUT FOUR MONTHS AND EVENTUALLY IT HAS A
SAFETY VALVE WHICH IS CLOSED AND IN ABOUT FOUR MONTHS TIME, IT
OPENS UP AUTOMATICALLY.
IT'S PROGRAMMED TO DO THAT.
AND THEN DEFLATES AND PASSES IN THE STOOL.
>> THAT'S IT, NO SURGERY.
SO THAT KEEPS THEM SATISFIED, IT HELPS WITH THE APPETITE?
>> CORRECT.
THE IDEA IS THAT, YOU KNOW, WE EAT THE FOOD, OCCUPIES A SPACE
IN THE STOMACH, AND THAT PRODUCES AITYITY AND YOU STOP
EATING THE FOOD IS PROCESSED BY THE
STOMACH, DIGESTED, PASSES INTO THE INTESTINES, SO YOU GET A
SENSE OF EMPTINESS AND YOU EAT AGAIN.
THE WHOLE IDEA OF THIS IS THAT IT'S PERMANENTLY IN THE STOMACH
FOR FOUR MONTHS.
IT PRODUCES A CONSTANT SENSE OF SATIETY.
>> IS THIS PRO SOMETHING THAT BE REPEATED OR IS THAT WHERE THE
WHOLE LIFESTYLE CHANGE IS WORKED IN?
>> CORRECT, VERY GOOD QUESTION.
IT CAN BE REPEATED, THAT'S ONE OF THE UNIQUE THINGS ABOUT AND
IT IN EUROPE I HAVE HAD EXPERIENCE OF PATIENTS DOING IT
TRYINGS.
I THINK THE IDEA OF THIS DEVICE, BUT EVEN WITH MORE AGGRESSIVE
METHODS LIKE SURGERY, IN MY OPINION, IF THE PATIENT AND THE
DOCTOR DOESN'T DEVOTE ENOUGH TIME TO REALLY CHANGE THE
LIFESTYLE, THE ACTIVITY LEVEL, THE BEHAVIOR DURING THE DAY, HOW
DO THEY, WHAT THEY DO EVERY DAY, HOW FOOD PLAYS INTO THE DALE
LIFE, AND IF YOU DON'T CHANGE ALL THESE THINGS, I THINK
EVENTUALLY ANYTHING YOU DO COULD POTENTIALLY FAIL.
SO MY PHILOSOPHY WITH THE DEVICE IS TO HELP THEM THROUGHOUT THIS
FOUR MONTHS TO CHANGE WHAT THEY DO, AND HOPEFULLY ONE WH THE
DEFER VICE IS OUT THEY DO THINGS IN A DIFFERENT WAY.
AND THAT CAN HELP THEM STAY HEALTHY AND MAINTAIN THE WEIGHT
LOSS.
OF COURSE, SOME PEOPLE THAT START FROM A VERY HIGH WEIGHT,
THEY MAY NOT BE ABLE TO ACHIEVE ALL THE WEIGHT LOSS THEY NEED
WITH ONE DEVICE, IN FOUR MONTHS.
IN THEORY COULD BE REPEATED A FEW MONTHS LATER AGAIN.
BUT THE WHOLE IDEA AGAIN, THE ULTIMATE GOAL IS TO CHANGE THEM,
REALLY MAKE THEM DO THINGS DIFFERENTLY IN THE LONG RUN.
OTHERWISE EVERYTHING WE DO IS TEMPORARY AND THEN ANYTHING CAN
HAPPEN.
>> SO YOU HAD SUCCESS IN EUROPE, OBVIOUSLY IT'S BEING SOLD
COMMERCIALLY NOW.
YOU HAVE 33 PATIENTS WHO HAVE DONE THIS SO FAR?
>> THAT'S RIGHT.
>> IN THIS AREA.
HOW HAVE THEY GONE?
AND ESPECIALLY, MY QUESTION IS ABOUT SWALLOWING THAT CAPSULE,
IS THERE ANXIETY WITH A STRING GOING DOWN THEIR THROAT AS WELL,
HOW HAVE THEY DONE WITH THAT?
>> I'M NOT GOING TO SAY IT'S THE EASIEST THING YOU DO EVERY DAY.
BUT I WAS FORTUNATE BECAUSE HAVING THE EXPERIENCE THAT I HAD
IN EUROPE AND HAVE DONE IT COMMERCIALLY IN GREECE FOR THE
LAST FEW YEARS, I HAVE UNDERSTOOD BETTER HOW TO TELL
THE PATIENTS HOW TO DO IT.
SO I CAN ASK THE COMPANY AFTER THE FIRST TRIAL TO DEVELOP A
PRACTICE CAPSULE, FIRST OF ALL, WOULD BE EXACTLY THE SAME SIZE
AS THE REAL CAPSULE SO PATIENTS CAN SEE IT BEFORE THE DAY OF
PLACEMENT AND TEACH THEM HOW TO ACTUALLY DO IT.
THAT MAKES A BIG DIFFERENCE.
SO I SPEND A LOT OF TIME EDUCATING AND PREPARING THE
PATIENTS IN ADVANCE AND THEY ARE MORE READY WHEN THEY COME TO DO
IT.
WE HAVEN'T HAD ANY ISSUE WITH ANY OF THEM.
NOT EVERYONE GETS THE REAL BALLOON, ABOUT TWO-THIRDS OF THE
PATIENTS INCLUDED WILL GET THE REAL BALLOON AND ABOUT A THIRD
WILL TAKE THE SHAM, WHICH IS EXACTLY THE SAME, BUT IT'S NOT
GOING TO BECOME A BALLOON.
THEN AT SIX MONTHS TIME WE'LL DISCLOSE WHAT THEY HAD AND
THEY'LL BE OFFERED THE OPPORTUNITY TO HAVE THE BALLOON
IN THE SECOND SIX MONTHS.
SO EVERYBODY WILL HAVE THE OPPORTUNITY TO HAVE THE REAL
BALLOON, BUT SOME WILL DO IT DURING THE SECOND PART OF THE
TRIAL.
ONE THING I WANT TO MENTION WHICH GOES ALONG WITH THE
DIFFICULTY SWALLOWING THIS, THERE IS AN ALTERNATIVE WAY TO
DO IT THE COMPANY PROVIDES A METALLIC
DEVICE THAT CAN BE PASSED THROUGH THE CATHETER, AND THEN I
CAN PASS IT THROUGH THE THROAT WITHOUT THEM EXPERIENCING IT.
BUT I ONLY HAD TO QUITE ONCE DURING THE TRIAL.
I FEEL IT'S A LITTLE MORE DIFFICULT EXPERIENCE FOR THE
PATIENT.
AND AVOIDING IT, I THINK, MAKES A NICER EXPERIENCE FOR THEM.
>> SO YOUR PATIENTS MUST BE HAPPY.
AT WHAT POINT DOES SURGERY BECOME THE ONLY OPTION FOR
PATIENTS THAT YOU'RE DEALING WITH?
>> THE BALLOON IS ACTUALLY DOING THE TRIAL FOR, IT'S ACTUALLY
DESIGNED FOR PATIENTS WITH B.M.I.
BETWEEN 30 AND 40.
30 IS THE BEGINNING OF OBESITY, AND B.M.I.
OF 40 IS BEGINNING OF MORBID OBESITY.
SO BASICALLY YOU HAVE TO HAVE A WEIGHT THAT IS OVER THE NORMAL
BETWEEN 30 AND 100 POUNDS.
SO AFTER THAT, FOR OVER 100-POUND THIS IS NOT INDICATED,
AND WON'T BE INDICATED IF IT BECOMES A SUCCESSFUL TRIAL.
SO SURGERY BECOMES THE ALTERNATIVE
OPTION FOR PATIENTS WITH B.M.I.
OVER 40.
IS THERE AN ALTERNATIVE INDICATION FOR SURGERY WHEN YOUR
B.M.I.
IS BETWEEN 35 AND 40, SO MIDWAY BETWEEN THE TWO RANGES I
MENTIONED BEFORE, BUT YOU HAVE TO HAVE ONE OTHER MEDICAL
CONDITION WITH IT.
AND WHAT WE LOOK FOR IS DIABETES, HEART DISEASE, SLEEP
APNEA, HIGH CHOLESTEROL AND HYPERTENSION.
SO THE PATIENTS MUST HAVE ONE OF THOSE, AND A B.M.I.
BETWEEN 35 AND 40.
IF THE BODY MASS INDEX IS OVER 40, THEN THEY ARE COMPLETELY
HEALTHY WITHOUT MEDICAL CONDITION THEY COULD QUALIFY FOR
SURGERY.
>> THANK YOU SO MUCH FOR COMING IN AND TALKING ABOUT THE ELLIPSE
BALLOON AND WE'LL BE FOLLOWING UP WITH YOU, AND BEST OF LUCK TO
THOSE PATIENTS AS WELL.