Endo-SPONGE for Anastomotic Leaks

(DRAIN Lower Trial)

Not yet recruiting at 4 trial locations

Overseen By Steve Fodem

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Under 18, Pregnant, Necrotic tissue, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Endo-SPONGE for leaks that can occur after colorectal surgery. The goal is to determine if this sponge-based vacuum therapy is safe and effective for healing these leaks. The trial seeks participants with a specific type of leak (anastomotic) in the lower pelvic area after surgery and a pre-existing ostomy (a surgically created opening). Participants must be able to undergo an endoscopic procedure, which allows doctors to look inside the body using a flexible tube. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Endo-SPONGE device is safe for treating anastomotic leaks?

Research has shown that Endo-SPONGE, used in endoscopic vacuum therapy to remove fluids and aid healing, is a safe and effective treatment for leaks after colorectal surgery. Studies have found that this therapy works well for patients and is generally successful.

In earlier research, Endo-SPONGE was used on patients with leaks after surgery to remove part of the esophagus. Even those with infections responded well to the treatment. Comparative studies also found that this therapy outperforms other methods for managing leaks after such surgeries.

While every treatment carries risks, current evidence supports the safety of Endo-SPONGE for treating surgical leaks. Always consult a healthcare professional about any concerns to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for anastomotic leaks, which often involve surgical interventions or prolonged use of antibiotics, the Endo-SPONGE utilizes an innovative endoscopic vacuum therapy (EVT) device. This approach is exciting because it promotes healing by continuously removing infectious material and fluids from the leak site, potentially reducing recovery times and complications. Researchers are particularly eager to explore how this less invasive technique could offer a more efficient and patient-friendly alternative to conventional methods.

What evidence suggests that the Endo-SPONGE device is effective for treating anastomotic leaks?

Research has shown that the Endo-SPONGE treatment, which participants in this trial will receive, effectively heals leaks after colorectal surgery. In one study, 90.9% of patients had their leaks closed after using this therapy, taking about 37 days on average. Another study found similar results, with 89.1% of patients experiencing successful healing, including a reduction in leak size. Additionally, Endo-SPONGE fully restored leaks in about 86.57% to 88.89% of cases. These findings suggest that Endo-SPONGE is a promising option for patients with these challenging leaks. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric Pauli, MD

Principal Investigator

Penn State Health

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced leaks at surgical connections (anastomotic leaks) or from the end of the intestine left after surgery (Hartmann's stump leakages) in the lower pelvic area following colorectal surgery.

Inclusion Criteria

I understand what the trial involves and agree to follow its procedures.

Investigator decision that EVT is the most suitable treatment of the available treatment options

I have a grade B leak at the surgery site in my gut.

Exclusion Criteria

I need a procedure to clean dead tissue before getting an Endo-SPONGE.

Potentially vulnerable subject, including, but not limited to pregnant women

Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of anastomotic or Hartmann's stump leakages

up to 3 months

Multiple visits for Endo-SPONGE exchanges

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of serious adverse events and clinical success

3 months

Extended Follow-up

Participants are monitored for additional outcomes such as leak recurrence and mortality rate

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Endo-SPONGE

Trial Overview The study is testing Endo-SPONGE, a sponge-based Endoscopic Vacuum Therapy (EVT), to see if it's safe and effective in treating anastomotic or Hartmann's stump leakages after colorectal surgeries.

How Is the Trial Designed?

Group I: Endoscopic Vacuum Therapy (EVT) Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5670284/

Long-term efficacy of vacuum-assisted therapy (Endo- ... Ten out 11 patients (90.9%) showed closure of the anastomotic leakage after a mean of 16 (range: 9-23) sponge changes performed over a mean of 37 (range: 18-65) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589845022000811

Endoscopic vacuum therapy for anastomotic leakage after ... Our results show that the median duration of EVT was 23 days with a median of 5,5 vacuum sponge changes per patient. However, in patients with large defects and ...

3. e-ce.org e-ce.org/journal/view.php?number=7888

Efficacy of endoscopic vacuum therapy in esophageal ... The complete restoration of postsurgical anastomotic leak and full thickness perforation was shown in 86.57% (95% CI, 81.94%–90.61%) and 88.89% ...

4. igiejournal.org igiejournal.org/article/S2949-7086(24)00093-1/fulltext

Endoscopic vacuum therapy Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7885467/

Feasibility, effectiveness, and safety of endoscopic vacuum ... The overall successful healing of the anastomotic leakages was achieved in 49 of 55 patients (89.1%). These patients had a reduction of the cavity size and ...

6. elsevier.es elsevier.es/en-revista-gastroenterologia-hepatologia-english-edition--382-pdf-download-S2444382420301541

Safety and efficacy of endoscopic vacuum therapy for the ... Anastomotic dehiscence was diagnosed a median (min- imum/maximum) of 5 (1---28) days following surgery. Four. (36%) patients underwent repeat surgery and one ...

7. tgh.amegroups.org tgh.amegroups.org/article/view/8884/html

Endoscopic vacuum therapy: pitfalls, tips and tricks, insights ... SEMS for treatment of anastomotic leaks <3 cm post-oncologic Ivor-Lewis showed no statistically significant results in terms of leaks resolution (90.9% EVT × ...