Ancora-SB Overtube for Small Bowel Disease

Recruiting at 4 trial locations

Overseen By Chris Schultz, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aspero Medical, Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Gastric bypass, Foregut surgery, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

123 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant and antiplatelet medications for the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Ancora-SB Overtube for Small Bowel Disease?

Research shows that spiral enteroscopy, a component of the Ancora-SB Overtube treatment, is safe and effective for managing small bowel issues, with favorable diagnostic results compared to other methods. Additionally, double-balloon enteroscopy, another component, is widely accepted for its ability to thoroughly examine and treat the small bowel, improving clinical outcomes. ^{1 2 3 4 5}

Is the Ancora-SB Overtube for Small Bowel Disease safe for humans?

The Ancora-SB Overtube, similar to other small bowel endoscopy techniques like spiral enteroscopy and push enteroscopy, is generally considered safe for humans. These procedures have been performed thousands of times worldwide with a low risk of complications, making them a reliable option for examining and treating small bowel conditions. ^{1 2 4 5 6}

What makes the Ancora-SB Overtube treatment for small bowel disease unique?

The Ancora-SB Overtube treatment is unique because it uses a spiral enteroscopy technique, which involves a special over-tube system to help doctors reach deep into the small bowel more effectively than traditional methods. This approach can be easier and more efficient, especially for less experienced operators, compared to other techniques like double-balloon or single-balloon enteroscopy. ^{7 8 9 10 11}

What is the purpose of this trial?

Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.

Eligibility Criteria

This trial is for adults aged 18-90 with small bowel disease, who can consent and follow study rules. They must be safe for single balloon enteroscopy (ASA Class I-III) and have lesions in the middle third of the small bowel identified by video capsule endoscopy.

Inclusion Criteria

I am considered low to moderate risk for complications from a specific type of endoscopy.

You are ready and capable of adhering to all study protocols and subsequent assessments.

My small bowel examination showed lesions in the middle part.

Exclusion Criteria

I have had gastric bypass surgery.

Pathology identified by video capsule is in the proximal 1/3 of the bowel

Your doctor expects you to live less than six (6) months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo enteroscopy using either the Ancora-SB or Olympus ST-SB1 Balloon Overtube to identify lesions in the small intestine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the enteroscopy procedure

4 weeks

Treatment Details

Interventions

• Enteroscopy

Trial Overview The trial aims to show that the Ancora-SB balloon Overtube is better than the Olympus ST-SB1 Balloon Overtube during endoscopic procedures for viewing and positioning within the small intestine.

Participant Groups

Group I: Ancora-SB Overtube Active Control 1 Intervention

Enteroscopy with Ancora-SB Balloon Overtube

Group II: Olympus ST-SB1 Overtube Active Control 1 Intervention

Enteroscopy with Olympus ST-SB1 Overtube

Enteroscopy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Enteroscopy for:

• Diagnosis and treatment of small intestine diseases
• Removal of polyps
• Diagnosis of bleeding areas
• Stretching or widening of strictures
• Collection of foreign bodies
• Biopsy collection

Approved in European Union as Enteroscopy for:

• Diagnosis and treatment of small intestine diseases
• Removal of polyps
• Diagnosis of bleeding areas
• Stretching or widening of strictures
• Collection of foreign bodies
• Biopsy collection

Approved in Japan as Enteroscopy for:

• Diagnosis and treatment of small intestine diseases
• Removal of polyps
• Diagnosis of bleeding areas
• Stretching or widening of strictures
• Collection of foreign bodies
• Biopsy collection

Who Is Running the Clinical Trial?

Aspero Medical, Inc.

Lead Sponsor

Trials

1

Recruited

120+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Spiral enteroscopy is a safe and effective technique for evaluating small bowel conditions, with over 3000 cases performed globally, showing favorable results in diagnostic yield and procedure time compared to traditional methods.

Push enteroscopy is also a reliable method for detecting and treating issues in the proximal gut, with low complication rates, making it a valuable option when other advanced techniques are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spiral enteroscopy and push enteroscopy. Akerman, PA., Cantero, D.[2012]

Recent advancements in small bowel endoscopy techniques, including capsule endoscopy and various enteroscopy methods, have significantly improved the ability to investigate the small intestine.

These new procedures, while effective, are complex and time-consuming, highlighting the need for careful consideration of technical issues and potential complications during their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques, tricks, and complications of enteroscopy. Lo, SK.[2012]

In a study involving 32 Japanese patients, spiral enteroscopy successfully diagnosed small intestinal lesions in 50% of cases, including various conditions such as malignant lymphomas and ulcers.

The procedure was found to be safe, with only one case of Mallory-Weiss syndrome reported and no perforations, indicating that while spiral enteroscopy is technically demanding, it can be performed without serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of spiral enteroscopy in Japanese patients: study in two tertiary hospitals. Yamada, A., Watabe, H., Oka, S., et al.[2013]

In a study of 14 children with suspected small bowel diseases, double-balloon push enteroscopy successfully diagnosed conditions in 85.7% of cases, revealing lesions in 12 out of 14 patients.

The procedure was found to be safe, with no severe complications reported, making it a reliable diagnostic tool for evaluating small bowel diseases in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of double-balloon push enteroscopy in diagnosis of small bowel disease in children]. Xu, CD., Deng, CH., Zhong, J., et al.[2019]

Double balloon enteroscopy is a safe and effective technique for examining the small bowel in patients with suspected bleeding, allowing for complete examination and therapeutic interventions.

Single balloon enteroscopy and a novel overtube device also show promise in deep enteroscopy, providing viable alternatives that can access areas of the small bowel previously only reachable through surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small bowel enteroscopy. Upchurch, BR., Vargo, JJ.[2012]

In a study of 523 patients undergoing retrograde enteroscopy, double-balloon enteroscopy (DBE) demonstrated a significantly shorter procedure time (26.5 minutes) compared to single-balloon enteroscopy (SBE) (34.8 minutes), indicating greater efficiency.

DBE also achieved a greater depth of insertion (108.1 cm) compared to SBE (73.3 cm), while both techniques showed similar rates of technical success and diagnostic yield, suggesting that DBE may be a more effective option for certain procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of double- versus single-balloon retrograde enteroscopy. Garg, R., Singh, A., Mohammed, A., et al.[2023]

Spiral enteroscopy was successfully performed in all 11 patients, allowing for deep intubation of the small bowel with an average insertion depth of 249 cm and a procedure time of about 28 minutes, making it a quick and effective technique.

No major complications occurred during the procedures, indicating that spiral enteroscopy is a relatively safe option for diagnosing conditions like obscure gastrointestinal bleeding and Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spiral enteroscopy: a preliminary experience in Asian population. Ramchandani, M., Reddy, DN., Gupta, R., et al.[2022]

Spiral enteroscopy is as safe as double-balloon enteroscopy for exploring the small bowel, with both techniques showing similar diagnostic and therapeutic success rates (70% for double-balloon and 75% for spiral).

While spiral enteroscopy showed a slight advantage in the average length of small bowel explored (220 cm vs. 200 cm) and procedure time (55 min vs. 60 min), these differences were not statistically significant, indicating comparable efficacy between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter comparison of double-balloon enteroscopy and spiral enteroscopy. Rahmi, G., Samaha, E., Vahedi, K., et al.[2022]

The Discovery SB overtube allows for safe and effective advancement of the enteroscope into the distal small bowel, with no reported perforations and low trauma scores in the majority of patients during procedures performed by inexperienced endoscopists.

After just five training cases, the endoscopists achieved a significant increase in depth of insertion from day 1 to day 2, indicating that the device is user-friendly and can lead to improved performance with minimal training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). Buscaglia, JM., Dunbar, KB., Okolo, PI., et al.[2022]

Overtube-assisted enteroscopy (OAE) demonstrated high sensitivity (89%) and specificity (97%) for detecting small-bowel polyps and tumors, based on a systematic review of 15 studies involving 821 patients.

OAE and capsule endoscopy (CE) showed a high rate of diagnostic concordance, indicating that both methods are effective for evaluating small-bowel conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overtube-assisted enteroscopy and capsule endoscopy for the diagnosis of small-bowel polyps and tumors: a systematic review and meta-analysis. Sulbaran, M., de Moura, E., Bernardo, W., et al.[2022]

In a study of 80 single balloon enteroscopy procedures performed over six years, the main reason for the procedure was to investigate obscure gastrointestinal bleeding, with successful diagnoses including small bowel angiodysplasias (20%) and yeyuno-ileal ulcers (17.5%).

The procedure was generally safe, with no respiratory or hemodynamic complications reported during sedation; however, paralytic ileus occurred in two cases, both linked to the absence of carbon dioxide insufflation during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Single balloon enteroscopy in the management of small bowel pathology. Experience of the Small Bowel Unit - British American Hospital from December 2012 to December 2018]. Cedrón Cheng, HG., Chirinos Vega, JA.[2020]

References

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

Spiral enteroscopy and push enteroscopy. [2012]

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

Techniques, tricks, and complications of enteroscopy. [2012]

3. Australia pubmed.ncbi.nlm.nih.gov

Feasibility of spiral enteroscopy in Japanese patients: study in two tertiary hospitals. [2013]

4. China pubmed.ncbi.nlm.nih.gov

[Application of double-balloon push enteroscopy in diagnosis of small bowel disease in children]. [2019]

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

Small bowel enteroscopy. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of double- versus single-balloon retrograde enteroscopy. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Spiral enteroscopy: a preliminary experience in Asian population. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Multicenter comparison of double-balloon enteroscopy and spiral enteroscopy. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Overtube-assisted enteroscopy and capsule endoscopy for the diagnosis of small-bowel polyps and tumors: a systematic review and meta-analysis. [2022]

11. Peru pubmed.ncbi.nlm.nih.gov

[Single balloon enteroscopy in the management of small bowel pathology. Experience of the Small Bowel Unit - British American Hospital from December 2012 to December 2018]. [2020]