Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 143 | |
| Control Arm (Standard Colonoscopy) | 124 |
Last reviewed · How we verify
EndoRings Colonoscopy vs Standard Colonoscopy
NA trial testing EndoRings device in Colorectal Adenoma in 592 participants. Completed in 13 September 2018.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 592 |
| Start date | 19 January 2018 |
| Primary completion | 13 September 2018 |
| Estimated completion | 13 September 2018 |
| Sites | 1 location across United States |
Indiana University
Eligibility, any sex, with Colorectal Adenoma or Colorectal Polyp. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 143 | |
| Control Arm (Standard Colonoscopy) | 124 |
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 1.46 | ± 2.69 |
| Control Arm (Standard Colonoscopy) | 1.06 | ± 1.83 |
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 199 | |
| Control Arm (Standard Colonoscopy) | 188 |
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 2.29 | ± 3.09 |
| Control Arm (Standard Colonoscopy) | 1.82 | ± 2.19 |
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 415 | |
| Control Arm (Standard Colonoscopy) | 295 |
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 650 | |
| Control Arm (Standard Colonoscopy) | 506 |
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 281 | |
| Control Arm (Standard Colonoscopy) | 277 |
Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 6.3 | ± 4.4 |
| Control Arm (Standard Colonoscopy) | 5.5 | ± 3.4 |
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 11.8 | ± 6.1 |
| Control Arm (Standard Colonoscopy) | 12.8 | ± 5.9 |
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 19.4 | ± 8.2 |
| Control Arm (Standard Colonoscopy) | 19.5 | ± 7.9 |
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 0.47 | ± 1.1 |
| Control Arm (Standard Colonoscopy) | 0.36 | ± 0.9 |
Occurrences of slippage of EndoRings or of device being removed on insertion.
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 17 |
| Group | Value | 95% CI |
|---|---|---|
| EndoRings Colonoscopy | 25 |
The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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