Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
NCT ID:
NCT03550118
Description:
None
Frequency Threshold:
0
Time Frame:
Each participant was monitored over the course of their involvement in each Arm's tests, which ranged from same day observations to up to two weeks of out-of-lab testing.
Study:
NCT03550118
Study Brief:
Auto Control of Volume Management for Limb Loss
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Aim 2 - Adjustable Socket - Researcher Controls | An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 15 | 0 | 15 | View |
| Aim 3 - Adjustable Socket - Participant Controls | An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on socket size adjustments while walking. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 13 | 0 | 13 | View |
| Aim 4 - Adjustable Socket - Automatic Controls | An adjustable socket is tested where a control system is used to automatically control the adjustments. This arm focuses on socket size adjustments while walking. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 12 | 0 | 12 | View |
| Stress-Sensing Liner | An adjustable socket is tested in addition to a prosthetic liner with embedded stress sensors to measure mechanical stresses as the socket is adjusted. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 9 | 0 | 9 | View |
| Aim 6A - Release/Recovery - Researcher Controls | An adjustable socket is tested where researchers control the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 13 | 0 | 13 | View |
| Aim 6B - Release/Recovery - Participant Controls | An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 7 | 0 | 7 | View |
| Aim 8 - Panel Pull During Resting | The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 14 | 0 | 14 | View |
| Aim 9 - Panel Pull During Ambulation | Extending from the Aim #8 results, we sought to determine in Aim #9 if "vacuum-like" action during ambulation facilitated limb fluid volume recovery and retention. Vacuum-like action was achieved by quickly pulling the panels and liner (liner attached to panels) radially outward during late stance phase and then moving them back to their original position during early swing. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 12 | 0 | 12 | View |
| Aim 10 - Adjustable Socket Out of Lab Testing | Participants took the investigational device home in one of three test modes. In the first mode, the panels were in a "locked" flush position, similar to their traditional prosthesis. Participants were not able to adjust the panels in this first mode. The second mode allowed participants to manually make panel adjustments, incrementally enlarging or tightening the panels radially. Lastly, the third mode implemented the automated controller developed in the previous aims. Participants were still able to make manual adjustments to the panel positions but during walks adjustments would also occur automatically. Each mode was tested for a minimum of 1 week. Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume. | 0 | None | 0 | 18 | 0 | 18 | View |
Serious Events(If Any):
Other Events(If Any):