Osto-Ring Study

Has anyone participated in the Osto-Ring study? I believe it is related to the Hollister 2pc pouch.

I sent for info, but haven't heard anything back. I believe the prior trial study was restricted to Hollister 2-piece barriers, but this time it's anyone's 2-piece. But I could, of course, be wrong. I'll let you know for sure when I get my info.

;O)

Hi Little,

I finally got an email response back from the guys doing the OstoRing study. Here's what they say:

The OstoRing® is a surgical grade stainless steel ring and is an add-on modifier to the Hollister 2-piece drainable ostomy pouch (this product is only compatible with the Hollister system). The OstoRing® requires a small adjustment to normal changing procedures. It connects between the flange on the skin barrier seal and the flange on the pouch. This connection tightens and improves the seal between your abdomen and pouching system due to the OstoRing® carrying the weight of the pouch instead of the adapt barrier ring wafer so that the seal remains flat against your abdomen, resulting in the connection remaining intact, leakproof, and durable. The OstoRing® aims to increase ostomy bag wear time and prevent leakage.

So there you have it. I'd say just don't let your bag get so full, but what do I know? I'm just glad there are people out there trying to invent ostomy products to make our lives better! Gotta love that!

;O)

Hi w30bob, thanks for the info. I haven't used a lot of 2pc but am willing to try anything that allows greater activity and leak-free confidence. I will keep an eye out for the Osto-Ring if it moves from trial to market. Thanks again.

I applied, but they will not deal with a Canadian.

Words of Encouragement from Ostomy Advocates I Hollister

Hi everyone.  I participated in the ostoring study and like it pretty well.  It does extend the wafer life and helps prevent leakage.  The only negative is the holster belt which over time will roll up on my side and can get to be a little uncomfortable.  Other than that I feel like the ring works great.  

I would like the info on the study please.

Hi Fur,

Here's the info I got... not sure if this trial is still ongoing or what, but I'll include the email address of the person who sent me this info!

;O)

Hello Bob,

Thank you for reaching out and for your interest in the Osto-Ring study!

I am the study coordinator at Alimentiv assisting with the OstoRing study. Alimentiv is an IBD CRO, and we are conducting a new study for patients with ileostomies to assess the performance of a novel ostomy ring device called the OstoRing® to improve ostomy function. The OstoRing® is a surgical grade stainless steel ring and is an add-on modifier to the Hollister 2-piece drainable ostomy pouch (this product is only compatible with the Hollister system). The OstoRing® requires a small adjustment to normal changing procedures. It connects between the flange on the skin barrier seal and the flange on the pouch. This connection tightens and improves the seal between your abdomen and pouching system due to the OstoRing® carrying the weight of the pouch instead of the adapt barrier ring wafer so that the seal remains flat against your abdomen resulting in the connection remaining intact, leakproof, and durable. The OstoRing® aims to increase ostomy bag wear time and prevent leakage. For interested participants, the study is a total of 6 weeks (2 weeks of standard of care and the following 4 weeks using the OstoRing®).

I have included the exhaustive list of the inclusion and exclusion criteria below:

Inclusion Criteria: Your answer must be Yes to the following questions to qualify for this trial (you will not be able to check the boxes).

1. Are you 18 years or older, and able to provide consent for yourself?

Yes ☐ No ☐

2. Have you had an end or loop ileostomy for at least 6 months?

Yes ☐ No ☐

3. Have you been using a Hollister New Image™ Two-Piece Drainable Ostomy Pouch for at least 8 weeks prior to this screening call?

Yes ☐ No ☐

4. Do you have an ileostomy with a diameter of 57mm (2.24 inches) or less?

Yes ☐ No ☐

5. Do you change your pouching system at least two times every seven days?

Yes ☐ No ☐

6. During the OstoRing® use portion of the trial, do you agree to wear the OstoRing® and the Hollister Adapt™ Ostomy Belt continuously, 24 hours a day for 4 weeks?

Yes ☐ No ☐

7. Are you able to read, write, and understand English for the purpose of consent, the completion of the study Workbooks, and telephone interviews?

Yes ☐ No ☐

8. Do you have access to the internet and an electronic device like a cell phone or tablet to be able to take and send images of the peristomal area and communicate with myself, the study coordinator?

Yes ☐ No ☐

9. Do you live in the U.S.?

Yes ☐ No ☐

Exclusion Criteria: Your answer MUST be no to the following questions to qualify for this trial (you will not be able to check the boxes).

1. Are you currently pregnant or breastfeeding?

Yes ☐ No ☐

2. In the last 2 months have you received or are currently receiving chemotherapy or radiation therapy?

Yes ☐ No ☐

3. In the last month, have you used any steroid treatment?

Yes ☐ No ☐

4. Are you currently suffering from any skin problems near your stoma such as:

a. Peristomal pyoderma

b. Abscess

c. Redness or other discoloration

d. Erosion/Excoriation (i.e., do you feel compelled to pick at your skin?)

e. Tissue Overgrowth

Yes ☐ No ☐

If yes, describe which one:

5. Do you have a peristomal hernia?

Yes ☐ No ☐

6. Do you have any known hypersensitivity (undesirable allergic reactions) toward the test product (OstoRing® is made of surgical grade stainless steel)?

Yes ☐ No ☐

7. In the last 30 days, have you participated or are you currently participating in a clinical study?

Yes ☐ No ☐

If you meet all of the inclusion and exclusion criteria and seem like you may be eligible for the study, we could set up a call to discuss the trial more in depth and confirm your eligibility.

Kind regards,

Rachel (email = ostostudy@alimentiv.com)

** Please note that I will try to respond to you as soon as possible, but due to the high volume of emails I have been receiving, please be patient as it might take me longer than usual to get back to you (1 to 2 weeks).

Sent: Wednesday, March 6, 2024 11:25 PM
To: ostostudy
Subject: OstoRing study info

Dear Valued Customers,

My name is Richard O'Hamill. I am the CEO of Stealth Belt Inc. and the designer of the Stealth Belt.

I am writing to tell you about another product that I think is truly beneficial for everyone with an ostomy.

One of my Stealth Belt customers has invented a patented, low-profile device called “The OstoRing®️" that in my personal experience not only prevented leakage, flange failure, and skin irritation but dramatically extended the wear life of the ostomy flange and pouch.

Early on I was fortunate to be able to personally test this new invention while doing my physically challenging training to become a WingTsun KungFu™ Instructor, a very physical and combative martial arts system popularized by Bruce Lee.

The OstoRing®️ certainly increased my confidence and allowed me to fully focus on the task at hand. My testing included direct abdominal kicks, grappling, and strikes. At the time of testing, none of my instructors knew I had an ostomy.

In both athletics and my normal day-to-day life, the OstoRing®️ gives me confidence and security that my Hollister system will not leak or fail—even under extreme circumstances.

The OstoRing®️ is now undergoing a formal, academic study. If you're interested in learning more and participating at no cost in the trial, I encourage you to call the number below—or email them—for more details.

CEO, Richard O'Hamill, Stealth Belt, Inc.

Go anywhere or do anything.

Email ostostudy@alimentiv.com for more information!