TECR & ECM Placement for Esophageal High Grade Dysplasia

NCT02396745 | Terminated Results FDA Device

• 1 other identifier: 12-024
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.

Conditions

Barrett Esophagus; Esophagus; High Grade Dysplasia

Outcome Measures

Primary Outcomes (4)

• Efficacy: Stricture Formation

  To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.

  12 months following procedure

• Efficacy: Recurrent Disease

  To evaluate incidence of recurrence of BE with HGD through 12 months following TECR with ECM placement. Incidence of disease recurrence will be confirmed endoscopically with pathology confirmed biopsies at 2 weeks, Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without disease recurrence at the trial endpoints will be compared to historical data.

  12 months following procedure

• Safety: Acute (Serious System and Procedure Related Adverse Events)

  To demonstrate the acute safety of TECR with ECM placement for treatment of BE with HGD by evaluating all serious system and procedure related adverse events occurring in the first 2 weeks post procedure.

  Two weeks following procedure

• Safety: Long-term (Study Related Adverse Events)

  To demonstrate the long-term safety of TECR with ECM placement for treatment of BE with HGD by evaluating all study related adverse events occurring more than 2 weeks post procedure through 12 months post procedure.

  Two weeks through 12 months post procedure

Secondary Outcomes (3)

• Stent Migration

  2 weeks

• Stent Integrity (e.g. Stent Fracture)

  2 weeks

• Additional Interventions (Number of Subsequent Follow up Treatment Interventions)

  12 months

Study Arms (1)

TECR & ECM

EXPERIMENTAL

Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM)

Device: Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))

Interventions

Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) DEVICE

TECR will be performed to resect the entire length and area of BE lesion. ECM PLACEMENT: Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA).

Also known as: ACell, Inc. MatriStem® Surgical Matrix PSMX, Boston Scientific, WallFlex™ Fully Covered Esophageal Stent

TECR & ECM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age and no more than 80 years of age.
• Have an established diagnosis of HGD
• a. Specific diagnosis and grading will be determined by pathology review of biopsy tissue collected during baseline EGD as part of a patient's standard of care.
• Have no evidence of lymphovascular invasion.
• Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
• Diameter of affected tissue must warrant circumferential excision a. Subjects must have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are normal (contain no HGD) they must be located on separate levels in two different quadrants.
• \. Must be an appropriate or reasonable surgical candidate. 6. Have demonstrated an understanding and signed an approved informed consent form for participation in this study.

You may not qualify if:

• Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal adenocarcinoma).
• a. Those requiring endoscopic submucosal dissection (ESD) are not eligible for this study
• Have presence of lymphovascular invasion.
• Require resection length longer than 10 cm.
• Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
• Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).
• Are pregnant or planning to become pregnant.
• Have coagulation disorders.
• Have a known hypersensitivity to porcine-based materials.
• Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
• Has a clinically significant psychological illness that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
• Are unable or unwilling to provide informed consent and/or fulfill the protocol follow-up requirements.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (16)

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MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Mara Yerk, Administrative Director
• Organization: Allegheny Singer Research Institute

mara.yerk@ahn.org

412-389-3059

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Esophageal and Lung Institute

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 24, 2015
• Study Start: January 25, 2016
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)