Trial Outcomes & Findings for TECR & ECM Placement for Esophageal High Grade Dysplasia (NCT NCT02396745)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

12 months following procedure

Results posted on

2019-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	TECR & ECM Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TECR & ECM Placement for Esophageal High Grade Dysplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TECR & ECM n=1 Participants Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months following procedure

Population: Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months following procedure

Population: Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Two weeks following procedure

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.

Outcome measures

Outcome measures
Measure	TECR & ECM n=1 Participants Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Safety: Acute (Serious System and Procedure Related Adverse Events)	1 Participants

PRIMARY outcome

Timeframe: Two weeks through 12 months post procedure

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.

Outcome measures

Outcome measures
Measure	TECR & ECM n=1 Participants Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Safety: Long-term (Study Related Adverse Events)	1 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed

To record the incidence of stent migration at 2 weeks post procedure. Stent migration will be determined endoscopically, and defined as any movement from initial deployment location greater than 1cm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed

To record incidences of poor stent integrity during removal (e.g. stent fracture).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed

To record the number of subsequent follow up treatment interventions (aside from study-related follow up time points) required post-procedure through 12 months.

Outcome measures

Outcome data not reported

Adverse Events

TECR & ECM

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TECR & ECM n=1 participants at risk Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Gastrointestinal disorders Dysphagia	100.0% 1/1 • Number of events 20 • 1 year, 10 months

Other adverse events

Other adverse events
Measure	TECR & ECM n=1 participants at risk Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)): 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).
Gastrointestinal disorders Dysphagia	100.0% 1/1 • Number of events 1 • 1 year, 10 months

Additional Information

Mara Yerk, Administrative Director

Allegheny Singer Research Institute

Phone: 412-389-3059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place