Trial Outcomes & Findings for A Comparison of Eleview Versus Hetastarch as Injectate for EMR (NCT NCT03350217)
NCT ID: NCT03350217
Last Updated: 2019-12-17
Results Overview
Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.
COMPLETED
PHASE4
160 participants
During the large polyp removal
2019-12-17
Participant Flow
Participant milestones
| Measure |
Eleview
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
81
|
|
Overall Study
COMPLETED
|
77
|
81
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Eleview Versus Hetastarch as Injectate for EMR
Baseline characteristics by cohort
| Measure |
Eleview
n=77 Participants
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=81 Participants
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
65.6 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
66.4 Years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
24 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=93 Participants
|
81 participants
n=4 Participants
|
158 participants
n=27 Participants
|
|
Number of lesions randomized in the study
|
114 Lesions
n=93 Participants
|
102 Lesions
n=4 Participants
|
159 Lesions
n=27 Participants
|
PRIMARY outcome
Timeframe: During the large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Sydney Resection Quotient (SRQ)
Adenomas
|
9.3 Ratio
Standard Deviation 6.2
|
8.1 Ratio
Standard Deviation 4.9
|
|
Sydney Resection Quotient (SRQ)
Serrated
|
12.3 Ratio
Standard Deviation 4.0
|
11.1 Ratio
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: During initial injection portion of large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Injected Volume Needed for Initial Lesion Lift
Adenomas
|
10.4 milliliters
Standard Deviation 5.4
|
11.6 milliliters
Standard Deviation 7
|
|
Injected Volume Needed for Initial Lesion Lift
Serrated
|
7.1 milliliters
Standard Deviation 4.9
|
8.7 milliliters
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Injected Volume Needed for Complete Removal of Lesion
Adenomas
|
14.8 milliliters
Standard Deviation 13.1
|
20.6 milliliters
Standard Deviation 20.9
|
|
Injected Volume Needed for Complete Removal of Lesion
Serrated Lesions
|
7.8 milliliters
Standard Deviation 5.7
|
10.7 milliliters
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Number of Re-injections Needed During Resection
Adenomas
|
0.61 reinjections
Standard Deviation 1.3
|
1.01 reinjections
Standard Deviation 1.6
|
|
Number of Re-injections Needed During Resection
Serrated Lesions
|
0.1 reinjections
Standard Deviation 0.31
|
0.3 reinjections
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 84 adenomas and 30 serrated lesions included in the Eleview arm. For the same reason, there are 81 patients but 75 adenomas and 27 serrated lesions in the Hetastarch group.
Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch
Outcome measures
| Measure |
Eleview
n=114 Large Polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large Polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Number of En Bloc Resections
Adenomas
|
18 Polyps
|
14 Polyps
|
|
Number of En Bloc Resections
Serrated Lesions
|
2 Polyps
|
2 Polyps
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Number of Pieces Resected Using Snares
Adenomas
|
4.5 polyp pieces resected
Standard Deviation 5
|
5.5 polyp pieces resected
Standard Deviation 5.3
|
|
Number of Pieces Resected Using Snares
Serrated Lesions
|
7 polyp pieces resected
Standard Deviation 5.9
|
8.2 polyp pieces resected
Standard Deviation 7
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be.
Outcome measures
| Measure |
Eleview
n=114 Large Polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large Polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Mound Concentration Diameter
Excellent
|
64 Polyps
|
54 Polyps
|
|
Mound Concentration Diameter
Sufficient
|
41 Polyps
|
41 Polyps
|
|
Mound Concentration Diameter
Inadequate
|
9 Polyps
|
7 Polyps
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be.
Outcome measures
| Measure |
Eleview
n=114 Large Polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large Polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Mound Concentration Height
Excellent
|
67 Polyps
|
58 Polyps
|
|
Mound Concentration Height
Sufficient
|
37 Polyps
|
38 Polyps
|
|
Mound Concentration Height
Inadequate
|
10 Polyps
|
6 Polyps
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.
Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating.
Outcome measures
| Measure |
Eleview
n=114 Large Polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large Polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Mound Duration
Inadequate
|
11 Polyps
|
5 Polyps
|
|
Mound Duration
Unknown
|
2 Polyps
|
0 Polyps
|
|
Mound Duration
Excellent
|
60 Polyps
|
58 Polyps
|
|
Mound Duration
Sufficient
|
41 Polyps
|
39 Polyps
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.
Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult.
Outcome measures
| Measure |
Eleview
n=114 Large Polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large Polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Ease of Injection
Very easy
|
52 Polyps
|
46 Polyps
|
|
Ease of Injection
Easy
|
58 Polyps
|
52 Polyps
|
|
Ease of Injection
Difficult
|
3 Polyps
|
3 Polyps
|
|
Ease of Injection
Very difficult
|
0 Polyps
|
0 Polyps
|
|
Ease of Injection
Unknown
|
1 Polyps
|
1 Polyps
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.
avulsion
|
37 Polyps requiring additional treatments
|
36 Polyps requiring additional treatments
|
|
Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.
soft coagulation
|
72 Polyps requiring additional treatments
|
55 Polyps requiring additional treatments
|
|
Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.
ablation
|
9 Polyps requiring additional treatments
|
7 Polyps requiring additional treatments
|
SECONDARY outcome
Timeframe: During the large polyp removalPopulation: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion)
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Time Required to Remove the Lesion
Adenomas
|
14.8 minutes
Standard Deviation 11.4
|
16.02 minutes
Standard Deviation 13.9
|
|
Time Required to Remove the Lesion
Serrated Lesions
|
5.9 minutes
Standard Deviation 4.2
|
7.1 minutes
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: during large polyp removal through 30 days post procedurePopulation: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate.
Outcome measures
| Measure |
Eleview
n=114 Large polyps
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=102 Large polyps
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Safety Outcomes as Assessed by Complications During or After the Procedure
Intraprocedural bleeding
|
18 Polyps
|
14 Polyps
|
|
Safety Outcomes as Assessed by Complications During or After the Procedure
Delayed Bleeding
|
1 Polyps
|
1 Polyps
|
|
Safety Outcomes as Assessed by Complications During or After the Procedure
Post procedure abdonimal pain
|
0 Polyps
|
1 Polyps
|
|
Safety Outcomes as Assessed by Complications During or After the Procedure
Perforation
|
1 Polyps
|
0 Polyps
|
Adverse Events
Eleview
Hetastarch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eleview
n=77 participants at risk
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
Hetastarch
n=81 participants at risk
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intraprocedural Bleeding
|
18.2%
14/77 • Number of events 18 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
16.0%
13/81 • Number of events 14 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Delayed Bleed
|
1.3%
1/77 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.2%
1/81 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Abdominal Pain
|
0.00%
0/77 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
1.2%
1/81 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
|
Injury, poisoning and procedural complications
Type 3 Deep Mural Injury
|
1.3%
1/77 • Number of events 1 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
0.00%
0/81 • 1 month
Patients were called approximately 30 days after their colonoscopy procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place