COLO BT™ Device for Colorectal Surgery Recovery

(COLO-BT Trial)

Recruiting at 2 trial locations

Overseen By Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JSR Medical Co., Ltd.

Must not be taking: Antidepressants, Steroids

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate during surgery

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the COLO-BT™, which may aid recovery after colorectal surgery by reducing stool contact with the healing site. Researchers aim to determine if this device improves outcomes compared to the usual care, which involves creating a temporary stoma to divert waste. Suitable participants have undergone or are scheduled for colorectal surgery and have a surgical connection (anastomosis) expected to be located between 4 cm and 15 cm from the anus. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery methods for future patients.

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 prior data suggests that the COLO-BT™ device is safe for colorectal surgery recovery?

Research shows that the COLO-BT™ device is designed as a safe option for patients undergoing colorectal surgery. This device temporarily prevents contact between stool and the surgical area. Although specific safety data from earlier studies is unavailable, testing the COLO-BT™ suggests it has shown promise in initial evaluations. Devices at this stage are generally expected to be well-tolerated. While detailed reports on side effects might not yet be available, the focus remains on assessing its safety and effectiveness in real-world surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The COLO BT™ device is unique because it aims to enhance recovery from colorectal surgery without the need for a protective stoma, which is the current standard of care. Unlike traditional methods that rely on creating a temporary stoma to protect the surgical site, COLO BT™ is designed to support healing internally, potentially reducing the discomfort and lifestyle disruptions associated with a stoma. Researchers are excited about COLO BT™ because it could lead to quicker recovery times, fewer complications, and a more comfortable postoperative experience for patients.

What evidence suggests that the COLO-BT™ device is effective for colorectal surgery recovery?

Research has shown that the COLO-BT™ device, which participants in this trial may receive, might aid healing after colorectal surgery by keeping waste away from the surgical site. This could reduce the risk of anastomotic leaks, which occur when the new connection between two parts of the colon doesn't heal properly. Studies suggest that innovations like COLO-BT™ can enhance the safety and effectiveness of these surgeries. Although specific data from human trials remains limited, the device may prevent healing problems caused by waste contact, a common issue in these surgeries. Early signs indicate this method might improve recovery. Meanwhile, another group in this trial will receive the standard of care, a protective stoma, during colorectal surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Mark A Falvo, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• COLO-BT™
• Stoma Creation

Trial Overview 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.

How Is the Trial Designed?

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)

Who Is Running the Clinical Trial?

JSR Medical Co., Ltd.

Lead Sponsor

Trials

1

Recruited

260+

Published Research Related to This Trial

A 47-year-old man successfully healed from colorectal anastomosis ischaemia after receiving 11 sessions of hyperbaric oxygen treatment (HBOT) over three weeks, demonstrating the potential efficacy of HBOT in promoting healing in such cases.

Endoscopic and radiological evaluations showed complete healing of the anastomosis two months post-treatment, with satisfactory anal function and no complications, suggesting that HBOT could be a valuable option for selected patients with similar post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment for late low colorectal anastomosis ischaemia: Case report. Sanzi, M., Aiolfi, A., Marin, JN., et al.[2022]

The newly developed drug-coated balloon (DCB) using polyethylene oxide (PEO) demonstrated comparable tissue retention levels of paclitaxel to a commercially available DCB in a study involving 10 pigs and 20 vessels over 30 days.

The PEO balloon released significantly fewer particulates, particularly large ones, compared to the commercially available DCB, suggesting it may be a safer option with reduced risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons. Anderson, JA., Lamichhane, S., Vierhout, T., et al.[2018]

A targeted recovery program for patients after bowel surgery has been effective in reducing hospital readmission rates.

Patients also experienced shorter hospital stays, indicating improved recovery outcomes from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bowel surgery recovery scheme proves a success. [2017]

In a study of 541 laparoscopic colorectal surgeries, compliance with an enhanced recovery program led to shorter hospital stays and reduced complications, highlighting the importance of following recovery protocols.

Key factors for successful recovery included low opiate use, full compliance with the recovery program, and having a surgeon with high case volume, all of which contributed to quicker discharges within 48 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after implementation of a multimodal standard care pathway for laparoscopic colorectal surgery. Larson, DW., Lovely, JK., Cima, RR., et al.[2022]

A new lever-based device has been developed to improve the speed of balloon inflation and deflation during valvuloplasty procedures, which could enhance the efficiency of the treatment.

In vitro testing demonstrated that this device significantly reduces the time required for balloon inflation and deflation, potentially leading to better outcomes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new device for balloon inflation during valvuloplasty: a preliminary report. Hill, JA., Martin, DB., Carr, AM.[2019]

The double balloon occlusion technique (DBOT) demonstrated a 100% procedural success rate and a 94% clinical success rate in treating acute graft thrombosis in 32 patients, indicating its efficacy in salvaging thrombosed grafts.

Despite one case of severe hematoma, the DBOT showed promising results with a 70% graft patency rate at 3 months, suggesting it is a safe and effective option for managing acute graft failures, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous management of acutely thrombosed hemodialysis grafts: the double balloon occlusion technique. Lai, CC., Kang, PL., Tsai, HL., et al.[2016]

The 360 Express balloon catheter demonstrated a high efficacy in treating Barrett's esophagus, with a median regression of 90% in 30 patients after radiofrequency ablation (RFA).

The procedure was relatively safe, with a low adverse event rate of 13%, and it achieved complete eradication of dysplasia in 97% of cases, indicating its effectiveness as a treatment option.

NCBI (Pubmed)

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. Belghazi, K., Pouw, RE., Sondermeijer, C., et al.[2022]

The Rosso catheter, designed for oral surgery, features an S-shaped intra-facial part that conforms to the airway, making it easy to insert and secure during procedures.

This catheter allows for clear access to the surgical field while providing the anesthetist with effective control over the patient's ventilation, enhancing both safety and efficacy in anesthesia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A rational naso-tracheal catheter]. Berling, C.[2006]

The article discusses enhanced recovery protocols for patients after colorectal surgery, which aim to improve patient outcomes and speed up recovery times.

These protocols likely include evidence-based practices that help reduce complications and promote quicker return to normal activities post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based nursing is the cornerstone of our profession. Sharples, K.[2019]

In a study of 606 laparoscopic colorectal resections, 46% of patients were safely discharged within 3 days post-surgery, demonstrating the feasibility of accelerated discharge protocols.

The readmission rate was low at 4%, indicating that enhanced recovery programs for laparoscopic surgery can minimize complications and improve patient outcomes compared to traditional methods.

NCBI (Pubmed)

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. Gash, KJ., Greenslade, GL., Dixon, AR.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05826743

Safety and Effectiveness Evaluation of the COLO-BT as an ... The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-4-2023-98834

COLO BT™ Device for Colorectal Surgery Recovery A 47-year-old man successfully healed from colorectal anastomosis ischaemia after receiving 11 sessions of hyperbaric oxygen treatment (HBOT) over three weeks, ...

3. research.buffalo.edu research.buffalo.edu/portal/clinicaltrial/protocol/24121

Clinical Trial - COLO-BT Study - research.buffalo.edu The goal of this study is to investigate the safety and effectiveness of the COLO-BT (Colorectal Balloon Tube) device for people needing colon resection surgery ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05826743/safety-and-effectiveness-evaluation-of-the-colo-bt-as-an-alternative-treatment-to-the-ileostomy

Safety and Effectiveness Evaluation of the COLO-BT as an ... The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12500728/

Advanced innovations in reducing anastomotic leak This review highlights the potential of these innovations to enhance the safety and efficacy of colorectal cancer surgeries, ultimately ...

6. ancora.ai ancora.ai/en/details/NCT05826743

Safety and Effectiveness Evaluation of the COLO-BT as ... The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal ...