COLO BT™ Device for Colorectal Surgery Recovery

(COLO-BT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Mark A Falvo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: JSR Medical Co., Ltd.

Must not be taking: Antidepressants, Steroids

Disqualifiers: Pregnancy, Emergency surgery, Severe liver damage, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking steroids of 20mg/day or more, you may not be eligible to participate.

What data supports the effectiveness of the COLO-BT™ treatment for colorectal surgery recovery?

Research on enhanced recovery programs for colorectal surgery shows that these programs can reduce complications and shorten hospital stays, which suggests that similar approaches, like the COLO-BT™ treatment, may also be effective in improving recovery after surgery.

^{1 2 3 4 5}

How is the COLO-BT™ treatment different from other treatments for colorectal surgery recovery?

The COLO-BT™ treatment is unique because it uses a balloon tube specifically designed for colorectal surgery recovery, which may help in managing post-surgical complications by providing targeted support and pressure to the affected area. This approach is different from standard treatments that might not use such a device to aid recovery.

^{6 7 8 9 10}

Eligibility Criteria

Adults aged 19-80 needing colorectal surgery with anastomosis between 4-15cm from the anus. Must have one risk factor like obesity, smoking, diabetes, stage III+ cancer, or pre-surgery chemo/radiation. Excludes those with severe medical conditions, recent major surgeries affecting the area, emergency surgery needs, pregnant/breastfeeding women, and certain blood disorders.

Inclusion Criteria

I agree to participate in the study and follow its rules.

I am willing to receive a blood transfusion if needed.

My surgical connection is between 4cm and 15cm from my anus.

Exclusion Criteria

I have severe diverticulosis.

I am not pregnant or breastfeeding.

I have a psychiatric or neurological disorder that affects my mobility or communication.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COLO BT™ or standard of care during colorectal surgery

Immediate during surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Participant Groups

The COLO-BT™ device is being tested to see if it can reduce complications after colorectal surgery by preventing fecal matter from contacting the surgical site. Participants will be randomly assigned to use this device or undergo standard stoma creation.

Group I: COLO BT™ Experimental Treatment 1 Intervention

Patients receive COLO BT™ during colorectal surgery.

Group II: Standard of Care Active Control 1 Intervention

Patients receive the standard of care, a protective stoma, during colorectal surgery.

COLO-BT™ is already approved in United States for the following indications:

🇺🇸 Approved in United States as COLO-BT for:

• Colorectal surgery (open or laparoscopic)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo Buffalo, NY

Baylor College of Medicine Houston, TX

PennState Health - Milton S. Hershey Medical Center Hershey, PA

Who Is Running the Clinical Trial?

JSR Medical Co., Ltd. Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Bowel surgery recovery scheme proves a success. [2017] A targeted recovery programme for patients after having bowel surgery has reduced readmission rates and time spent in hospital.

2. England pubmed.ncbi.nlm.nih.gov

Evidence-based nursing is the cornerstone of our profession. [2019] I read with interest nurse Jennie Burch's learning zone article (September 12) on enhanced recovery for patients following colorectal surgery.

3. England pubmed.ncbi.nlm.nih.gov

Outcomes after implementation of a multimodal standard care pathway for laparoscopic colorectal surgery. [2022] The aim of the study was to assess which aspects of an enhanced recovery programme are associated with better outcomes following laparoscopic colorectal surgery.

4. England pubmed.ncbi.nlm.nih.gov

Enhanced recovery after laparoscopic colorectal resection with primary anastomosis: accelerated discharge is safe and does not give rise to increased readmission rates. [2022] Enhanced recovery programmes after colorectal surgery are promoted to minimize complications and expedite recovery, thus reducing length of hospital stay where appropriate and improving the overall standard of patient care. There are few published trials of enhanced recovery programmes in the context of laparoscopic colorectal surgery.

5. Australia pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment for late low colorectal anastomosis ischaemia: Case report. [2022] This report describes the use of hyperbaric oxygen treatment (HBOT) to treat a case of colorectal anastomosis ischaemia following colorectal surgery.

6. United States pubmed.ncbi.nlm.nih.gov

A new device for balloon inflation during valvuloplasty: a preliminary report. [2019] A new device using a lever concept has been designed to facilitate rapid inflation and deflation of balloons during valvuloplasty. This report summarizes and illustrates the design features of the balloon inflation device as well as in vitro results of testing of times for balloon inflation, deflation, and bursting.

7. United States pubmed.ncbi.nlm.nih.gov

Percutaneous management of acutely thrombosed hemodialysis grafts: the double balloon occlusion technique. [2016] The aim of this article is to introduce a new technique, named the "double balloon occlusion technique" (DBOT), for the salvage of acutely thrombosed grafts and to demonstrate its safety and efficacy.

8. England pubmed.ncbi.nlm.nih.gov

A single-step sizing and radiofrequency ablation catheter for circumferential ablation of Barrett's esophagus: Results of a pilot study. [2022] The 360 Express balloon catheter (360 Express) has the ability to self-adjust to the esophageal lumen, ensuring optimal tissue contact.

9. United States pubmed.ncbi.nlm.nih.gov

In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons. [2018] The purpose of this study was to investigate the newly developed drug-coated balloon (DCB) using polyethylene oxide (PEO) as a platform and to compare it directly with a commercially available DCB in a preclinical experimental setting.

10. France pubmed.ncbi.nlm.nih.gov

[A rational naso-tracheal catheter]. [2006] For the last 4 years, the author has been using, especially for oral surgery, a naso-tracheal catheter (Rosso catheter), the intra-facial part of which has an S-shape which follows the curves of the airway and the outer part of which, in reinforced latex, permits attachment to the face and easy, reliable connection to the anesthetic apparatus. This catheter is easy to introduce, keeps well in place and frees perfectly the operative field and gives the anesthetist satisfactory mastery of the patient's ventilation.